AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

THE REPORTING FACILITY INFORMATION IS THE FOLLOWING: FACILITY: (B)(6). ADDRESS: (B)(6). COUNTRY: UNITED STATES. STATE: (B)(6). CITY: (B)(6). ZIP CODE: (B)(6). PHONE: (B)(6). 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 RESULT: WITH THE INFORMATION AVAILABLE, BOSTON SCIENTIFIC CORPORATION CONFIRMED THE REPORTED EVENT OF STENT FAILURE TO DEPLOY AS THE STENT WAS RETURNED PARTIALLY DEPLOYED. THE REPORTED EVENT OF HANDLE BREAK WAS NOT CONFIRMED; NO DAMAGE WAS IDENTIFIED. THE INVESTIGATION CONCLUDED THAT THE ADDITIONAL OBSERVED DAMAGES ON THE DELIVERY SYSTEM WERE MOST LIKELY CAUSED BY PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE AND THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED), WHICH CONTRIBUTED TO THE STENT NOT BEING ABLE TO BE DEPLOYED APPROPRIATELY. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE COULD NOT BE PERFORMED SINCE THE LOT INFORMATION WAS UNAVAILABLE FROM THE CUSTOMER. DEVICE TECHNICAL ANALYSIS: AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPIC INSPECTIONS WERE PERFORMED. THE STENT WAS RETURNED PARTIALLY DEPLOYED WITH THE DELIVERY SYSTEM POSITION 4 OF THE DEPLOYMENT PROCESS. THE OUTER SHEATH WAS RETURNED CUT INTO THREE SECTIONS, SEPARATED, AND BENT. THE INNER SHEATH WAS RETURNED KINKED. THE DUAL LUMEN PROXIMAL PUSHER WAS RETURNED BENT. THE HANDLE WAS INSPECTED AND NO DAMAGE WAS IDENTIFIED. ADDITIONAL EVALUATION REQUIRED DESTRUCTIVE ANALYSIS OF THE DELIVERY SYSTEM TO ASSESS FOR POSSIBLE TORSIONAL (ROTATIONAL) DAMAGE. NO EVIDENCE OF ROTATIONAL DAMAGE WAS IDENTIFIED. NO OTHER DAMAGE WAS OBSERVED ON THE RETURNED DEVICE. 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 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 TRANSGASTRIC TO PANCREAS TO TREAT WALL-OFF NECROSIS DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE GREY HUB FAILED TO DEPLOY THE DISTAL FLANGE. THE HUB FLOATED LOOSELY AND WAS NOT ABLE TO DEPLOY THE STENT. THE STENT WAS RETRIEVED FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.