AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Description of Event or Problem

BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH AN ARTICLE TITLED, "LONG- TERM CLINICAL SUCCESS OF ENDOSCOPIC ULTRASOUND- GUIDED GASTROENTEROSTOMY IN BENIGN GASTRIC OUTLET OBSTRUCTION", BY MANUEL PEREZ- MIRANDA, ET AL. THE STUDY AIMED TO EVALUATE LONG-TERM CLINICAL OUTCOMES OF EUS-GE IN BENIGN GASTRIC OUTLET OBSTRUCTION (BGOO). ACCORDING TO THE ARTICLE, A MULTICENTER RETROSPECTIVE STUDY WAS CONDUCTED ACROSS NINE CENTERS INVOLVING PATIENTS WHO UNDERWENT EUS-GE FOR THE TREATMENT OF BGOO. PATIENTS SCHEDULED FOR EUS-GE WITH LAMS BETWEEN JANUARY 2017 AND JUNE 2023 WERE CONSIDERED ELIGIBLE. THERE WERE 62 PATIENTS INCLUDED FOR ANALYSIS. MOST CASED OF BGOO WERE RELATED TO PANCREATIC DISEASE. PER THE ARTICLE, ONE FATAL BLEEDING WAS DOCUMENTED. A 59-YEAR-OLD PATIENT WITH CHROMIC PANCREATITIS WHO EXPERIENCED EPISODE OF LAMS DYSFUNCTION NECESSITATING MULTIPLE ENDOSCOPIC SALVAGE PROCEDURE. (LAMS EXCHANGES, COAXIAL SEMS PLACEMENT), DEVELOPED PRESSURE ULCERS AT THE JEJUNAL SIDE OF THE ANASTOMOSIS. THE PATIENT DIED FROM MASSIVE GASTROINTESTINAL BLEEDING 718 DAYS POST-INITIAL STENT PLACEMENT. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS PLACED TO TREAT A BENIGN GASTRIC OUTLET OBSTRUCTION. HOWEVER, THE AXIOS STENT ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE STATE THAT "THE AXIOS STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF: A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH GREATER THAN OR EQUAL TO 70% FLUID CONTENT; THE GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK FOR, OR UNSUITABLE FOR, SURGERY; AND THE BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE." THE STENT IS NOT INTENDED TO TREAT A BENIGN GASTRIC OUTLET OBSTRUCTION.

Additional Manufacturer Narrative

BLOCK B3: APPROXIMATED BASED ON THE DATE THE STUDY WAS CONDUCTED. BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT UPN AND 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. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE SOURCE: MANUEL PEREZ-MIRANDA, ET. AL., ": LONG- TERM CLINICAL SUCCESS OF ENDOSCOPIC ULTRASOUND- GUIDED GASTROENTEROSTOMY IN BENIGN GASTRIC OUTLET OBSTRUCTION" DIGESTIVE ENDOSCOPY, 2025; 37:1198-1206. HTTPS://DOI.ORG/10.1111/DEN.15087. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF GASTROINTESTINAL BLEEDING. IMDRF PATIENT CODE E2339 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PRESSURE ULCERS. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT'S DEATH. IMDRF IMPACT CODE F2202 CAPTURES THE ADDITIONAL ENDOSCOPIC PROCEDURE. IMDRF IMPACT CODE F2301 CAPTURES THE USE OF ADDITIONAL DEVICE.

Description of Event or Problem

BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH AN ARTICLE TITLED, "LONG- TERM CLINICAL SUCCESS OF ENDOSCOPIC ULTRASOUND- GUIDED GASTROENTEROSTOMY IN BENIGN GASTRIC OUTLET OBSTRUCTION", BY MANUEL PEREZ- MIRANDA, ET AL. THE STUDY AIMED TO EVALUATE LONG-TERM CLINICAL OUTCOMES OF EUS-GE IN BENIGN GASTRIC OUTLET OBSTRUCTION (BGOO). ACCORDING TO THE ARTICLE, A MULTICENTER RETROSPECTIVE STUDY WAS CONDUCTED ACROSS NINE CENTERS INVOLVING PATIENTS WHO UNDERWENT EUS-GE FOR THE TREATMENT OF BGOO. PATIENTS SCHEDULED FOR EUS-GE WITH LAMS BETWEEN (B)(6) 2017 AND (B)(6) 2023 WERE CONSIDERED ELIGIBLE. THERE WERE 62 PATIENTS INCLUDED FOR ANALYSIS. MOST CASED OF BGOO WERE RELATED TO PANCREATIC DISEASE. PER THE ARTICLE, ONE FATAL BLEEDING WAS DOCUMENTED. A 59-YEAR-OLD PATIENT WITH CHROMIC PANCREATITIS WHO EXPERIENCED EPISODE OF LAMS DYSFUNCTION NECESSITATING MULTIPLE ENDOSCOPIC SALVAGE PROCEDURE. (LAMS EXCHANGES, COAXIAL SEMS PLACEMENT), DEVELOPED PRESSURE ULCERS AT THE JEJUNAL SIDE OF THE ANASTOMOSIS. THE PATIENT DIED FROM MASSIVE GASTROINTESTINAL BLEEDING 718 DAYS POST-INITIAL STENT PLACEMENT. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS PLACED TO TREAT A BENIGN GASTRIC OUTLET OBSTRUCTION. HOWEVER, THE AXIOS STENT ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE STATE THAT "THE AXIOS STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF: A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH GREATER THAN OR EQUAL TO 70% FLUID CONTENT; THE GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK FOR, OR UNSUITABLE FOR, SURGERY; AND THE BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE." THE STENT IS NOT INTENDED TO TREAT A BENIGN GASTRIC OUTLET OBSTRUCTION.

Additional Manufacturer Narrative

BLOCK B3: APPROXIMATED BASED ON THE DATE THE STUDY WAS CONDUCTED. BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT UPN AND 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. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE SOURCE: MANUEL PEREZ-MIRANDA, ET. AL., ": LONG- TERM CLINICAL SUCCESS OF ENDOSCOPIC ULTRASOUND- GUIDED GASTROENTEROSTOMY IN BENIGN GASTRIC OUTLET OBSTRUCTION" DIGESTIVE ENDOSCOPY, 2025; 37:1198-1206. HTTPS://DOI.ORG/10.1111/DEN.15087. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF GASTROINTESTINAL BLEEDING IMDRF PATIENT CODE E2339 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PRESSURE ULCERS. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT'S DEATH. IMDRF IMPACT CODE F2202 CAPTURES THE ADDITIONAL ENDOSCOPIC PROCEDURE IMDRF IMPACT CODE F2301 CAPTURES THE USE OF ADDITIONAL DEVICE. BLOCK H11: INVESTIGATION RESULT: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED PATIENT COMPLICATIONS OF BLEEDING, ULCERATION AND DEATH COULD NOT BE CONFIRMED. THE DEVICE WAS NOT RETURNED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS UNABLE TO BE PERFORMED AS THE DEVICE UPN AND LOT NUMBER IS UNKNOWN, DEVICE TECHNICAL ANALYSIS: THE DEVICE WAS NOT RETURNED; THEREFORE, TECHNICAL ANALYSIS COULD NOT BE PERFORMED. LABELLING REVIEW: THE LABELING REVIEW FOUND EVIDENCE TO SUGGEST THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS. "THE AXIOS STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF: A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH GREATER THAN OR EQUAL TO 70% FLUID CONTENT; THE GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK FOR, OR UNSUITABLE FOR, SURGERY; AND THE BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE"; HOWEVER, IT WAS REPORTED THAT THE AXIOS STENT WAS PLACED TO TREAT A BENIGN GASTRIC OUTLET OBSTRUCTION. ADDITIONALLY, HEMORRHAGE, MAJOR, ULCERATION AND DEATH ARE NOTED WITHIN THE DFU AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE. RISK REVIEW: A REVIEW OF THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM DFMEA AND HAZARD ANALYSIS WERE COMPLETED AND CONFIRMED THAT THE EVENT OF HEMORRHAGE, MAJOR, ULCERATION, DEATH, AND ADDITIONAL DEVICE REQUIRED WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE IS CLASSIFIED AS A KNOWN INHERENT RISK OF THE DEVICE.