AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY. BLOCK H11: INVESTIGATION SUMMARY: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CORPORATION WAS UNABLE TO CONFIRM THE REPORTED EVENT OF STENT FAILURE TO DEPLOY. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISPOSED; THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION THE INVESTIGATION CONCLUDED THAT THERE IS NOT ENOUGH EVIDENCE TO DETERMINE IF THE REPORTED EVENT OF STENT FAILURE TO DEPLOY WAS DUE TO THE PHYSICIAN'S DEVICE MANIPULATION DURING THE PROCEDURE, OR WHETHER IT WAS RELATED TO A DEVICE MALFUNCTION. THE INVESTIGATION FINDINGS DID NOT LEAD TO A DEFINITIVE CONCLUSION REGARDING THE CAUSE OF THE REPORTED EVENTS; THE MOST PROBABLE CONTRIBUTING CAUSE REMAINS UNKNOWN. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE TECHNICAL ANALYSIS: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISPOSED; THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE REPORTED EVENTS OF STENT FAILURE TO DEPLOY 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. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN 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 TO BE IMPLANTED TRANSGASTRICALLY TO THE PANCREAS TO TREAT A PANCREATIC FLUID COLLECTION DURING A PSEUDOCYST DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED USING A DOUBLE PIGTAIL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.