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 RESULTS: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC COULD NOT CONFIRM THE REPORTED EVENT OF STENT FAILURE TO DEPLOY. THE DEVICE WAS NOT RETURNED AS IT WAS DISPOSED; THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. WITHOUT PROPER EVALUATION OF THE DEVICE, IT IS UNKNOWN IF THE REPORTED EVENT WAS DUE TO THE TECHNIQUE USED DURING THE PROCEDURE, ANATOMICAL CONDITIONS OR RELATED TO DEVICE MALFUNCTION. DEVICE HISTORY RECORD: 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 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 INTENDED TO BE IMPLANTED TRANSGASTRICALLY TO THE PANCREAS FOR TREATMENT OF A PANCREATIC FLUID COLLECTION DURING AN ENDOSCOPIC ULTRASOUND-GUIDED CYSTOGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, DEPLOYMENT OF THE FIRST FLANGE WAS ATTEMPTED; HOWEVER, IT DID NOT OPEN DESPITE MULTIPLE ATTEMPTS OVER APPROXIMATELY FIVE MINUTES. THE STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.