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. IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF HANDLE BREAK. 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 SUMMARY: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONFIRMED THE REPORTED EVENTS OF STENT FAILURE TO DEPLOY AND HANDLE BREAK. THE INVESTIGATION CONCLUDED THAT THERE REPORTED EVENTS AND OBSERVED EVENTS WERE LIKELY DUE TO PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED), WHICH COULD HAVE RESULTED IN THE DAMAGES ENCOUNTERED IN THE DEVICE. THEREFORE, THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS ADVERSE EVENT RELATED TO PROCEDURE. DEVICE HISTORY RECORDS REVIEW: A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. DEVICE TECHNICAL ANALYSIS: AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE RECEIVED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE STENT FULLY COVERED AND UNDEPLOYED, AND THE CONTROL HUB WAS DETACHED. NO OTHER PROBLEMS WERE NOTED WITH THE STENT AND DELIVERY SYSTEM. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF "STENT FAILURE TO DEPLOY AND HANDLE BREAK" WERE DEFINED IN THE RISK DOCUMENTATION AND ARE DOCUMENTED. THESE EVENT TYPES HAVE 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 IS ADVERSE EVENT RELATED TO PROCEDURE.

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 TO TREAT A PANCREATIC NECROSIS DURING A PSEUDOCYST DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE AXIOS STENT DID NOT DEPLOY, AND THE HANDLE WAS BROKEN. THE DEVICE WAS REMOVED, AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.