AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM AND A WALLFLEX BILIARY STENT WERE IMPLANTED FOR THE TREATMENT OF PANCREATIC CANCER VIA COMMON BILE DUCT (CBD) DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS)-DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE PERFORMED ON (B)(6) 2025. REPORTEDLY, THE AXIOS STENT WAS NOT POSITIONED CORRECTLY DURING THE IMPLANT PROCEDURE. THE PHYSICIAN THEN INSERTED A COAXIAL WALLFLEX STENT ENDOSCOPICALLY TO PREVENT MIGRATION AND SEAL ANY POTENTIAL LEAK. THE PATIENT DEVELOPED BILIARY SEPSIS DUE TO A SUBSEQUENT STENT MIGRATION, WHICH REQUIRED HOSPITALIZATION. THE PATIENT ULTIMATELY PASSED AWAY ON (B)(6) 2025. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED TO TREAT PANCREATIC CANCER THROUGH A COMMON BILE DUCT DRAINAGE (CBD) DURING AN ENDOSCOPIC ULTRASOUND (EUS)-DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH AT LEAST 70 PERCENT OF FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT INDICATED TO TREAT PANCREATIC CANCER DURING AN EDGE PROCEDURE.

Additional Manufacturer Narrative

BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION SUCH AS THE MANUFACTURE DATE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF IMPACT CODE F2301 CAPTURES THE EVENT OF AN ADDITIONAL REQUIRED. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION.

Additional Manufacturer Narrative

BLOCK A3A/A3B UPDATED FROM UNKNOWN TO FEMALE. BLOCK G4 (PREMARKET / 510(K) #) HAS BEEN UPDATED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION SUCH AS THE MANUFACTURE DATE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF IMPACT CODE F2301 CAPTURES THE EVENT OF AN ADDITIONAL REQUIRED. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION. BLOCK H11: INVESTIGATION RESULTS: WITH ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC CORPORATION CONCLUDES THAT THE REPORTED EVENT OF STENT POSITIONING ISSUE AND STENT MIGRATION WAS NOT ABLE TO BE CONFIRMED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THERE IS NOT ENOUGH EVIDENCE TO DETERMINE WHETHER THE STENT POSITIONING ISSUE AND STENT MIGRATION WAS DUE TO THE PHYSICIAN'S DEVICE MANIPULATION DURING THE PROCEDURE OR RELATED TO A DEVICE MALFUNCTION. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED AS THE REQUIRED DOCUMENTATION WAS UNAVAILABLE. DEVICE TECHNICAL ANALYSIS: THE COMPLAINT DEVICE WAS NOT RETURNED, THEREFORE; PRODUCT ANALYSIS COULD NOT BE PERFORMED. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF "STENT POSITIONING ISSUE, STENT MIGRATION, SEPSIS, DEATH, HOSPITALIZATION OR PROLONGED HOSPITALIZATION AND ADDITIONAL DEVICE REQUIRED" WERE DEFINED IN THE RISK DOCUMENTATION. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. LABELING REVIEW: A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL. THE IFU STATES: "THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH AT LEAST 70 PERCENT OF FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE"; HOWEVER, IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED TO TREAT PANCREATIC CANCER THROUGH A COMMON BILE DUCT DRAINAGE (CBD) DURING AN ENDOSCOPIC ULTRASOUND (EUS)-DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE. THE INSTRUCTIONS FOR USE (IFU) CONTAINS DETAILED DEVICE INFORMATION AND INSTRUCTIONS FOR THE DEVICE USE AND THERE IS NO EVIDENCE THAT THERE IS ANY ISSUE WITH TRANSLATION, WORDING, OR GRAPHICS OF THE IFU/LABELING INFORMATION. ADDITIONALLY, IT WAS CONFIRMED THAT THE FOLLOWING ADVERSE EVENTS ARE ANTICIPATED IN THE IFU: "STENT POSITIONING ISSUE, STENT MIGRATION, SEPSIS AND DEATH". INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM AND A WALLFLEX BILIARY STENT WERE IMPLANTED FOR THE TREATMENT OF PANCREATIC CANCER VIA COMMON BILE DUCT (CBD) DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS)-DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE PERFORMED ON (B)(6) 2025. REPORTEDLY, THE AXIOS STENT WAS NOT POSITIONED CORRECTLY DURING THE IMPLANT PROCEDURE. THE PHYSICIAN THEN INSERTED A COAXIAL WALLFLEX STENT ENDOSCOPICALLY TO PREVENT MIGRATION AND SEAL ANY POTENTIAL LEAK. THE PATIENT DEVELOPED BILIARY SEPSIS DUE TO A SUBSEQUENT STENT MIGRATION, WHICH REQUIRED HOSPITALIZATION. THE PATIENT ULTIMATELY PASSED AWAY ON (B)(6) 2025. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED TO TREAT PANCREATIC CANCER THROUGH A COMMON BILE DUCT DRAINAGE (CBD) DURING AN ENDOSCOPIC ULTRASOUND (EUS)-DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH AT LEAST 70 PERCENT OF FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT INDICATED TO TREAT PANCREATIC CANCER DURING AN EDGE PROCEDURE.

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. ADDITIONALLY, UPON REVIEW, IT WAS DETERMINED THAT BSC REFERENCE (b)(4) WAS SUBMITTED TO MHRA IN ERROR. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT BSC REFERENCE (b)(4) IS A DUPLICATE OF THE INCIDENT DOCUMENTED UNDER THIS REPORT AND A FINAL REPORT WILL BE SUBMITTED AGAINST (b)(4).IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM AND A WALLFLEX BILIARY STENT WERE IMPLANTED FOR THE TREATMENT OF PANCREATIC CANCER VIA COMMON BILE DUCT (CBD) DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS)-DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE PERFORMED ON (b)(6) 2025.REPORTEDLY, THE AXIOS STENT WAS NOT POSITIONED CORRECTLY DURING THE IMPLANT PROCEDURE. THE PHYSICIAN THEN INSERTED A COAXIAL WALLFLEX STENT ENDOSCOPICALLY TO PREVENT MIGRATION AND SEAL ANY POTENTIAL LEAK.THE PATIENT DEVELOPED BILIARY SEPSIS DUE TO A SUBSEQUENT STENT MIGRATION, WHICH REQUIRED HOSPITALIZATION. THE PATIENT ULTIMATELY PASSED AWAY ON (b)(6) 2025.THE POSSIBLE CAUSES OF THE DEATH BEING INVESTIGATED BY THE CORONER ARE BILIARY PERITONITIS, STENTING OF COMMON BILE DUCT AND OBSTRUCTIVE PANCREATIC CANCER.NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED TO TREAT PANCREATIC CANCER THROUGH A COMMON BILE DUCT DRAINAGE (CBD) DURING AN ENDOSCOPIC ULTRASOUND (EUS)-DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH AT LEAST 70 PERCENT OF FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT INDICATED TO TREAT PANCREATIC CANCER DURING AN EDGE PROCEDURE.

Additional Manufacturer Narrative

NOTE: BASED ON ADDITIONAL INFORMATION RECEIVED ON 08 JUN 2026, IT WAS DETERMINED THAT MDR REPORT NUMBER 3005099803-2026-02218 IS A DUPLICATE OF THIS EVENT. THUS, THE DUPLICATE COMPLAINT ASSOCIATED WITH MDR REPORT NUMBER 3005099803-2026-02218 HAS BEEN CLOSED INTERNALLY. ALL AVAILABLE AND RELEVANT INFORMATION PERTAINING TO THIS EVENT HAS BEEN INCLUDED IN MDR REPORT. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT WILL BE SUBMITTED AS A SUPPLEMENTAL MDR.BLOCK B5 HAS BEEN UPDATED.BLOCK D4, H4:THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION SUCH AS THE MANUFACTURE DATE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF IMPACT CODE F2301 CAPTURES THE EVENT OF AN ADDITIONAL REQUIRED.IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION.BLOCK H11:INVESTIGATION RESULTS:WITH ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC CORPORATION CONCLUDES THAT THE REPORTED EVENT OF STENT POSITIONING ISSUE AND STENT MIGRATION WAS NOT ABLE TO BE CONFIRMED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THERE IS NOT ENOUGH EVIDENCE TO DETERMINE WHETHER THE STENT POSITIONING ISSUE AND STENT MIGRATION WAS DUE TO THE PHYSICIAN'S DEVICE MANIPULATION DURING THE PROCEDURE OR RELATED TO A DEVICE MALFUNCTION.DEVICE HISTORY RECORD REVIEW:A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED AS THE REQUIRED DOCUMENTATION WAS UNAVAILABLE.DEVICE TECHNICAL ANALYSIS:THE COMPLAINT DEVICE WAS NOT RETURNED, THEREFORE; PRODUCT ANALYSIS COULD NOT BE PERFORMED.RISK REVIEW:A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF "STENT POSITIONING ISSUE, STENT MIGRATION, SEPSIS, DEATH, HOSPITALIZATION OR PROLONGED HOSPITALIZATION AND ADDITIONAL DEVICE REQUIRED" WERE DEFINED IN THE RISK DOCUMENTATION. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT.LABELING REVIEW:A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL. THE IFU STATES: "THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH AT LEAST 70 PERCENT OF FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE"; HOWEVER, IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED TO TREAT PANCREATIC CANCER THROUGH A COMMON BILE DUCT DRAINAGE (CBD) DURING AN ENDOSCOPIC ULTRASOUND (EUS)-DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE. THE INSTRUCTIONS FOR USE (IFU) CONTAINS DETAILED DEVICE INFORMATION AND INSTRUCTIONS FOR THE DEVICE USE AND THERE IS NO EVIDENCE THAT THERE IS ANY ISSUE WITH TRANSLATION, WORDING, OR GRAPHICS OF THE IFU/LABELING INFORMATION. ADDITIONALLY, IT WAS CONFIRMED THAT THE FOLLOWING ADVERSE EVENTS ARE ANTICIPATED IN THE IFU: "STENT POSITIONING ISSUE, STENT MIGRATION, SEPSIS AND DEATH".INVESTIGATION CONCLUSION:BASED ON A THOROUGH REVIEW OF THE COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.