AXIOS?

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 TRANSGASTRIC TO THE PANCREAS TO TREAT A PANCREATIC CYST DURING A PANCREATIC CYST GASTRIC DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, DEPLOYMENT OF THE DISTAL FLANGE WAS ATTEMPTED; HOWEVER, SEVERE RESISTANCE WAS FELT WHEN THE HANDLE WAS ACTUATED, RESULTING IN BREAKAGE OF THE STENT DEPLOYMENT HUB. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH, AND THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING ANOTHER AXIOS STENT. THERE WAS NO PATIENT INJURY REPORTED DUE TO THIS EVENT.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY. BLOCK H11: FOLLOWING AN UPDATE TO THE AXIOS RISK DOCUMENTATION, THIS EVENT IS BEING REPORTED AS PART OF THE EFFORTS ASSOCIATED WITH BOSTON SCIENTIFIC'S NONCONFORMING EVENTS AND PREVENTION INVESTIGATION, (B)(4). INVESTIGATION RESULTS: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC WAS ABLE TO CONFIRM THE REPORTED EVENTS OF STENT FAILURE TO DEPLOY AND HANDLE BREAK. THE DEVICE WAS RETURNED WITH THE STENT FULLY COVERED AND UNDEPLOYED; THE AXIOS DEVICE WAS RETURNED WITH THE STENT FULLY COVERED AND UNDEPLOYED. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE INVESTIGATION CONCLUDED THAT THE INVESTIGATION FINDING WAS MOST LIKELY DUE TO FACTORS ENCOUNTERED DURING THE PROCEDURE. IT MAY BE THAT LESION CHARACTERISTICS, HANDLING OF THE DEVICE AND THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED), LIMITED THE PERFORMANCE OF THE DEVICE AND CONTRIBUTED TO THE REPORTED EVENTS. 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: AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE RECEIVED FOR ANALYSIS. THE STENT WAS RECEIVED UNDEPLOYED AND FULLY COVERED BY THE OUTER SHEATH. THE DEPLOYMENT HUB WAS DETACHED AND WAS NOT RETURNED. NO ADDITIONAL PROBLEM WAS NOTED WITH THE STENT AND DELIVERY SYSTEM. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "STENT FAILURE TO DEPLOY" WAS DEFINED IN THE RISK DOCUMENTATION AND IS DOCUMENTED. 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 ADVERSE EVENT RELATED TO PROCEDURE.