AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOY IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. BLOCK H11: INVESTIGATION RESULTS: WITH ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC CORPORATION CONCLUDES THAT THE REPORTED EVENTS OF STENT MIGRATION AND STENT PARTIALLY DEPLOY WERE NOT CONFIRMED. THERE IS NO CLINICAL OR TECHNICAL EVIDENCE TO DETERMINE WHETHER THE PATIENT REPORTS SYMPTOMS WERE DUE TO A DEVICE MALFUNCTION OR STRUCTURAL COMPROMISE. DEVICE HISTORY RECORD REVIEW: IT WAS CONFIRMED THAT 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 THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED, FOR THIS REASON AND DUE TO THE LACK OF EVIDENCE IS UNABLE TO CONFIRM THE REPORTED EVENTS. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF "STENT PARTIALLY DEPLOYED, STENT MIGRATION AND ADDITIONAL DEVICE REQUIRED" 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: A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. ADDITIONALLY, STENT MIGRATION AND STENT PARTIALLY DEPLOYED IS NOTED WITHIN THE PRODUCT LABELING AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. INVESTIGATION CONCLUSION: BASED ON ALL GATHERED INFORMATION AND THE RESULTS OF THE PRODUCT ANALYSIS, THE COMPLAINT 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 PANCREATIC PSEUDOCYST TO TREAT PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND PROCEDURE PERFORMED ON (B)(6) 2026. REPORTEDLY, THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1-TO-1 FASHION. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THEY WERE USING FREE-HAND TECHNIQUE AND SUCCESSFULLY DEPLOYED THE DISTAL FLANGE BUT WHEN TRYING TO DEPLOY THE PROXIMAL FLANGE IT WOULD NOT OPEN. THE POSITION OF THE SCOPE WAS RETROFLEX, AND THE PHYSICIAN WAS USING A SIDEVIEW. THE PHYSICIAN TRIED TO PULL THE SCOPE TO DEPLOY THE STENT HOWEVER THE STENT MIGRATED TO THE STOMACH. THE DEVICE WAS ABLE TO BE REMOVED BY USING A RAT TOOTH FORCEPS AND THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING A HOT SPAXUS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.