TRIA FIRM URETERAL STENT SETS

Description of Event or Problem

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A010402,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;22901656,,,2/19/2026,Tria Firm Ureteral Stent Sets,"stent, ureteral","stent, ureteral",,UNK-P-Tria_Ureteral_Stent,,,K924608,2/19/2026,MA,"This report summarizes 59 incidents for displacement, and 31 incidents for mechanical complication. Device relationship to the events reported is not provided. ;;Type of Procedure: Patient outcomes for Tria Soft Ureteral stents approved for long indwell times in patients with known stent insertion and removal dates ;;Boston Scientific performed a retrospective review of the Boston Scientific Tria Soft Ureteral stents in the Truveta database. This analysis aimed to assess patient outcomes with ureteral stents approved for long indwell times. The procedures were performed from the years 2020-2025. Within this analysis, a total of 8,582 patients underwent Tria Ureteral stent insertion and removal. Following procedures involving Tria Soft Stents, 59 patients had a device displacement, and 31 patients had a mechanical complication.;;Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data includes newly implanted patients and follow up of patients included in the previous data set. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;Age: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%)","Timeframe of Event Data: Events from ureteral stent insertion and removal performed within the year of 2020-2025.;;Summary of Events: Following procedures in involving Tria Soft Ureteral stents, a total of 59 patient experienced stent displacement, and 31 had a mechanical complication.;;Device Evaluation: Under the terms and conditions of the Registry, anonymized data was provided. No products were returned as part of the Registry. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. As the device is not available for analysis, no physical or visual analysis of the product could be performed. The reported device performance allegation cannot be confirmed.;;Contextual Analysis of Study Data:;Displacement:;Displacement rates for ureteral stents identified in the clinical literature are reported as Dislodgement/Migration (including accidental/inadvertent dislodgement) rates and have a reported rate range of 0-15% in the clinical literature. The displacement rates identified in this activity for Tria Firm (1.3%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;Mechanical complication:;Mechanical complication rates for ureteral stents identified in the clinical literature are reported as Hardware malfunction/device fracture rates and have a reported rate range of 0.3-10%. The mechanical complication rates identified in this activity for Tria Firm (1.7%) and Tria Soft (1.7%) are within this rate range for Ureteral Stents.;;There were no unexpected adverse events in this study.;;1. Dellis A, Kallidonis P, Adamou C, et al. The efficacy and safety of string stents after retrograde intrarenal surgery for urolithiasis. Minerva Urol Nefrol. Aug 2020;72(4):451-463. ;2. Gauhar V, Pirola GM, Scarcella S, et al. Nephrostomy tube versus double J ureteral stent in patients with malignant ureteric obstruction. A systematic review and meta-analysis of comparative studies. Int Braz J Urol. Nov-Dec 2022;48(6):903-914. ;3. Wang X, Wu G, Wang T, et al. Meta-analysis of perioperative outcomes and safety of percutaneous nephrostomy versus retrograde ureteral stenting in the treatment of acute obstructive upper urinary tract infection. Ther Adv Urol. Jan-Dec 2024;16:17562872241241854. doi:10.1177/17562872241241854;4. Harrison NL, Hughes C, Somani BK. Is Stent on a String the New Gold Standard for Postureteroscopy Ureteral Drainage? Evidence from a Systematic Review. J Endourol. Feb 2024;38(2):159-169. ;5. Gordon P, Thompson D, Patel O, Ma R, Bolton D, Ischia J. Ureteric stenting outside of the operation theatre: challenges and opportunities. BJU Int. Oct 8 2024;;6. Ahmad MU, Siddiqui S, Ashraf FA, et al. Retrograde Ureteral Stents Versus Percutaneous Nephrostomy in the Management of Malignant Ureteral Obstruction: A Systematic Review and Meta-Analysis. Urology. Oct 2024;192:158-167. doi:10.1016/j.urology.2024.05.042;7. Fiuk J, Bao Y, Calleary John G, Schwartz Bradley F, Denstedt John D. The Use of Internal Stents in Chronic Ureteral Obstruction. Journal of Urology. 2015/04/01 2015;193(4):1092-1100. doi:10.1016/j.juro.2014.10.123;;Race: Asian 2.0%, Black 9.4%, Other Race 6.4%, Unknown 6.3%, and White 76%.;Ethnicity: Not Hispanic or Latino 86%, Hispanic or Latino 9.3%, and Unknown 4.2%.;;Product (Device) Details: ;The UPN is utilized to capture Tria Soft events. In the absence of an available ?unknown? UPN specific to Tria Soft, the Tria Firm UPN has been applied for reporting purposes.",,,,,,,E2403,F26,A0401; A04,G07001,B17,C19,D16,No,0;

Additional Manufacturer Narrative

TIMEFRAME OF EVENT DATA: EVENTS FROM URETERAL STENT INSERTION AND REMOVAL PERFORMED WITHIN THE YEAR OF 2020-2025. SUMMARY OF EVENTS: FOLLOWING PROCEDURES IN INVOLVING TRIA SOFT URETERAL STENTS, A TOTAL OF 59 PATIENT EXPERIENCED STENT DISPLACEMENT, AND 31 HAD A MECHANICAL COMPLICATION. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE REGISTRY. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS AS PART OF A PREVIOUSLY REPORTED SPONTANEOUS COMPLAINT. AS THE DEVICE IS NOT AVAILABLE FOR ANALYSIS, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. CONTEXTUAL ANALYSIS OF STUDY DATA: DISPLACEMENT: DISPLACEMENT RATES FOR URETERAL STENTS IDENTIFIED IN THE CLINICAL LITERATURE ARE REPORTED AS DISLODGEMENT/MIGRATION (INCLUDING ACCIDENTAL/INADVERTENT DISLODGEMENT) RATES AND HAVE A REPORTED RATE RANGE OF 0-15% IN THE CLINICAL LITERATURE. THE DISPLACEMENT RATES IDENTIFIED IN THIS ACTIVITY FOR TRIA FIRM (1.3%) AND TRIA SOFT (1.7%) ARE WITHIN THIS RATE RANGE FOR URETERAL STENTS. MECHANICAL COMPLICATION: MECHANICAL COMPLICATION RATES FOR URETERAL STENTS IDENTIFIED IN THE CLINICAL LITERATURE ARE REPORTED AS HARDWARE MALFUNCTION/DEVICE FRACTURE RATES AND HAVE A REPORTED RATE RANGE OF 0.3-10%. THE MECHANICAL COMPLICATION RATES IDENTIFIED IN THIS ACTIVITY FOR TRIA FIRM (1.7%) AND TRIA SOFT (1.7%) ARE WITHIN THIS RATE RANGE FOR URETERAL STENTS. THERE WERE NO UNEXPECTED ADVERSE EVENTS IN THIS STUDY. 1. DELLIS A, KALLIDONIS P, ADAMOU C, ET AL. THE EFFICACY AND SAFETY OF STRING STENTS AFTER RETROGRADE INTRARENAL SURGERY FOR UROLITHIASIS. MINERVA UROL NEFROL. AUG 2020;72(4):451-463. 2. GAUHAR V, PIROLA GM, SCARCELLA S, ET AL. NEPHROSTOMY TUBE VERSUS DOUBLE J URETERAL STENT IN PATIENTS WITH MALIGNANT URETERIC OBSTRUCTION. A SYSTEMATIC REVIEW AND META-ANALYSIS OF COMPARATIVE STUDIES. INT BRAZ J UROL. NOV-DEC 2022;48(6):903-914. 3. WANG X, WU G, WANG T, ET AL. META-ANALYSIS OF PERIOPERATIVE OUTCOMES AND SAFETY OF PERCUTANEOUS NEPHROSTOMY VERSUS RETROGRADE URETERAL STENTING IN THE TREATMENT OF ACUTE OBSTRUCTIVE UPPER URINARY TRACT INFECTION. THER ADV UROL. JAN-DEC 2024;16:17562872241241854. DOI:10.1177/17562872241241854. 4. HARRISON NL, HUGHES C, SOMANI BK. IS STENT ON A STRING THE NEW GOLD STANDARD FOR POSTURETEROSCOPY URETERAL DRAINAGE? EVIDENCE FROM A SYSTEMATIC REVIEW. J ENDOUROL. FEB 2024;38(2):159-169. 5. GORDON P, THOMPSON D, PATEL O, MA R, BOLTON D, ISCHIA J. URETERIC STENTING OUTSIDE OF THE OPERATION THEATRE: CHALLENGES AND OPPORTUNITIES. BJU INT. OCT 8 2024; 6. AHMAD MU, SIDDIQUI S, ASHRAF FA, ET AL. RETROGRADE URETERAL STENTS VERSUS PERCUTANEOUS NEPHROSTOMY IN THE MANAGEMENT OF MALIGNANT URETERAL OBSTRUCTION: A SYSTEMATIC REVIEW AND META-ANALYSIS. UROLOGY. OCT 2024;192:158-167. DOI:10.1016/J.UROLOGY.2024.05.042 7. FIUK J, BAO Y, CALLEARY JOHN G, SCHWARTZ BRADLEY F, DENSTEDT JOHN D. THE USE OF INTERNAL STENTS IN CHRONIC URETERAL OBSTRUCTION. JOURNAL OF UROLOGY. 2015/04/01 2015;193(4):1092-1100. DOI:10.1016/J.JURO.2014.10.123. RACE: ASIAN 2.0%, BLACK 9.4%, OTHER RACE 6.4%, UNKNOWN 6.3%, AND WHITE 76%. ETHNICITY: NOT HISPANIC OR LATINO 86%, HISPANIC OR LATINO 9.3%, AND UNKNOWN 4.2%. AGE: -24(2.6%), 25-44 (18%), 45-64 (36%), 65-74 (24%), +75 (19%). PRODUCT (DEVICE) DETAILS: THE UPN IS UTILIZED TO CAPTURE TRIA SOFT EVENTS. IN THE ABSENCE OF AN AVAILABLE UNKNOWN UPN SPECIFIC TO TRIA SOFT, THE TRIA FIRM UPN HAS BEEN APPLIED FOR REPORTING PURPOSES.

Description of Event or Problem

THIS REPORT SUMMARIZES 59 INCIDENTS FOR DISPLACEMENT, AND 31 INCIDENTS FOR MECHANICAL COMPLICATION. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. TYPE OF PROCEDURE: PATIENT OUTCOMES FOR TRIA SOFT URETERAL STENTS APPROVED FOR LONG INDWELL TIMES IN PATIENTS WITH KNOWN STENT INSERTION AND REMOVAL DATES BOSTON SCIENTIFIC PERFORMED A RETROSPECTIVE REVIEW OF THE BOSTON SCIENTIFIC TRIA SOFT URETERAL STENTS IN THE TRUVETA DATABASE. THIS ANALYSIS AIMED TO ASSESS PATIENT OUTCOMES WITH URETERAL STENTS APPROVED FOR LONG INDWELL TIMES. THE PROCEDURES WERE PERFORMED FROM THE YEARS 2020-2025. WITHIN THIS ANALYSIS, A TOTAL OF 8,582 PATIENTS UNDERWENT TRIA URETERAL STENT INSERTION AND REMOVAL. FOLLOWING PROCEDURES INVOLVING TRIA SOFT STENTS, 59 PATIENTS HAD A DEVICE DISPLACEMENT, AND 31 PATIENTS HAD A MECHANICAL COMPLICATION OF STENT BREAK AND DAMAGED. PATIENT EVENTS WERE IDENTIFIED AS EVENT TERMS WITH RATES. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT. DATA INCLUDES NEWLY IMPLANTED PATIENTS AND FOLLOW UP OF PATIENTS INCLUDED IN THE PREVIOUS DATA SET. DATA OBTAINED FROM TRUVETA FOR THIS STUDY IS DE-IDENTIFIED BEFORE BEING ACCESSED BY BOSTON SCIENTIFIC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO OUR ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED AS A SPONTANEOUS COMPLAINT. THE STUDY DATA DOES NOT PROVIDE A CAUSALITY RELATIONSHIP FOR EACH REPORTED EVENT TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE TO BSC.