AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE LOT NUMBER. WE ARE UNABLE TO PROVIDE THE DEVICE MANUFACTURE DATE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. BLOCK H11: INVESTIGATION RESULTS: WITH ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC CORPORATION CONCLUDES THAT THE REPORTED EVENT OF STENT FAILURE TO EXPAND WAS NOT CONFIRMED. THERE IS NOT ENOUGH EVIDENCE TO DETERMINE WHETHER THE EVENT WAS DUE TO THE PHYSICIAN'S DEVICE MANIPULATION DURING THE PROCEDURE OR RELATED TO A DEVICE MALFUNCTION. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE HISTORY RECORD REVIEW: THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE; PRODUCT ANALYSIS COULD NOT BE PERFORMED. RISK REVIEW A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "STENT FAILURE TO EXPAND" WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS 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, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. INVESTIGATION CONCLUSION: BASED ON ALL GATHERED INFORMATION AND THE RESULTS OF THE PRODUCT ANALYSIS, THE COMPLAINT INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED ON THE GALLBLADDER TO TREAT CHOLECYSTITIS DURING A GALLBLADDER DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE PROXIMAL FLANGE DIDNT OPEN. IT WAS ALSO MENTIONED THAT THE PROCEDURE WAS PROLONGED. IT WAS INDICATED THAT THE STENT WAS IMPLANTED IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.