AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF IMPACT CODE F14 CAPTURES THE REPORTABLE EVENT OF PROLONGED EPISODE OF CARE. BLOCK H11: INVESTIGATION RESULTS: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC COULD NOT CONFIRM THE REPORTED EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND AND STENT POSITIONING ISSUE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. WITHOUT PROPER EVALUATION OF THE DEVICE, IT IS UNKNOWN IF THE REPORTED EVENTS WERE DUE TO THE TECHNIQUE USED DURING THE PROCEDURE, ANATOMICAL CONDITIONS OR RELATED TO DEVICE MALFUNCTION. HOWEVER, STENT POSITIONING ISSUE IS NOTICED WITHIN THE INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. 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. RISK REVIEW A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF "STENT FIRST FLANGE FAILURE TO EXPAND, STENT POSITIONING ISSUE AND PROLONGED EPISODE OF CARE" WERE DEFINED IN THE RISK DOCUMENTATION. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. LABELING REVIEW: THE LABELING REVIEW FOUND EVIDENCE TO SUGGEST THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS. THE DEVICE INSTRUCTIONS FOR USE (IFU) STATES: "DO NOT REMOVE THE STENT FROM ITS DELIVERY SYSTEM PRIOR TO USE"; HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN WITHDREW THE STENT OUTSIDE THE PATIENT AND AN ATTEMPT WAS MADE TO OPEN THE CUP. EVENTUALLY, THE PHYSICIAN WAS ABLE TO OPEN THE STENT AND REINSERTED IT INSIDE THE PATIENT WHERE THEY SUCCESSFULLY DEPLOYED THE STENT. THE IFU CONTAINS DETAILED DEVICE INFORMATION AND INSTRUCTIONS FOR THE DEVICE USE AND THERE IS NO EVIDENCE THAT THERE IS ANY ISSUE WITH TRANSLATION, WORDING, OR GRAPHICS OF THE IFU/LABELING INFORMATION. ADDITIONALLY, STENT POSITIONING ISSUE IS NOTICED WITHIN THE IFU AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. 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 IN THE GALLBLADDER TO TREAT OBSTRUCTIVE BILIARY SYNDROME DURING A CHOLECYSTOGASTROSTOMY PERFORMED ON A UNKNOWN DATE. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT WHILE IN THE PATIENT THEY EXPERIENCED DIFFICULTY DEPLOYING THE STENT. THE SYSTEM WAS OPENED AND CLOSED MULTIPLE TIMES TO TRY AND INDUCE OPENING, BUT IT WAS UNSUCCESSFUL. THE PHYSICIAN WITHDREW THE STENT OUTSIDE THE PATIENT, AND AN ATTEMPT WAS MADE TO OPEN THE CUP. EVENTUALLY, THE PHYSICIAN WAS ABLE TO OPEN THE STENT AND REINSERTED IT INSIDE THE PATIENT WHERE THEY SUCCESSFULLY DEPLOYED THE STENT. HOWEVER, UPON FULLY DEPLOYING THE STENT IT SHIFTED AND REMAINED IN THE STOMACH WALL. THE PHYSICIAN REMOVED THE STENT AND WAS ABLE TO COMPLETE THE PROCEDURE BY DEPLOYING A SPAXUS STENT. IT WAS ALSO REPORTED THAT DUE TO THE ISSUES THE PROCEDURE WAS PROLONGED FOR 150 MINUTES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE PHYSICIAN WITHDREW THE STENT OUTSIDE THE PATIENT AND AN ATTEMPT WAS MADE TO OPEN THE CUP. EVENTUALLY, THE PHYSICIAN WAS ABLE TO OPEN THE STENT AND REINTERESTED INSIDE THE PATIENT WHERE THEY SUCCESSFULLY DEPLOYED THE STENT. THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE INSTRUCTIONS FOR USE (IFU).