AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

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 DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE AXIOS STENT FAILED TO DEPLOY. IT WAS ALSO REPORTED THAT THERE WAS A DELAY IN THE TREATMENT DUE TO THE ISSUE. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY BY USING AN ADDITIONAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AT THIS TIME.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY. BLOCK H11: INVESTIGATION SUMMARY: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC COULD NOT CONFIRM THE REPORTED EVENT OF STENT FAILURE TO DEPLOY. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THERE IS NOT ENOUGH EVIDENCE TO DETERMINE WHETHER THE STENT FAILURE TO DEPLOY WAS DUE TO THE PHYSICIAN'S DEVICE MANIPULATION DURING THE PROCEDURE OR RELATED TO A DEVICE MALFUNCTION. 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 DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT 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.