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. 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 RESULTS: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC COULD NOT CONFIRM THE REPORTED EVENT OF STENT FAILURE TO DEPLOY AS THE STENT WAS RECEIVED FULLY DEPLOYED. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT AND OBSERVED FINDINGS MAY HAVE BEEN DUE TO THE FAILURE TO FOLLOW THE MANUFACTURER'S INSTRUCTIONS. IT IS LIKELY THAT FAILURE TO FOLLOW THE MANUFACTURER'S INSTRUCTIONS BY INCORRECTLY ROTATING THE HANDLE, LED TO THE STENT BEING UNABLE TO DEPLOY. DEVICE HISTORY RECORD: 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: AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WERE RECEIVED FOR ANALYSIS. THE STENT WAS RECEIVED IN A FULLY DEPLOYED CONDITION. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE OUTER SHEATH WAS TWISTED, BUCKLED, AND DETACHED FROM THE DELIVERY SYSTEM. IT WAS NECESSARY TO DISASSEMBLE THE DELIVERY SYSTEM TO IDENTIFY THE TORSION (ROTATIONAL DAMAGE), WHICH CONFIRMED TWISTING OF THE SHEATH. FUNCTIONAL INSPECTION WAS ALSO PERFORMED; THE DEVICE WAS CONNECTED TO AN ENDOSCOPE FOR TESTING, AND NO CONNECTION ISSUES WERE OBSERVED. NO ADDITIONAL PROBLEM WAS NOTED WITH THE STENT AND DELIVERY SYSTEM. LABELING REVIEW: A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE IFU (INSTRUCTIONS FOR USE) / PRODUCT LABEL. THE COMPLAINANT REPORTED THAT THE HANDLE WAS ROTATED AS THE WINGNUT WAS NOT ATTACHING AND KEPT COMING LOOSE. ACCORDING TO THE EVIDENCE FOUND IN THE PRODUCT ANALYSIS, THE OUTER SHEATH WAS TWISTED, BUCKLED AND DETACHED FROM THE DELIVERY SYSTEM, WHICH IS EVIDENCE THAT THE LUER WAS INCORRECTLY ROTATED AS THE IFU STATES "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE." RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE REPORTED EVENTS 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 FAILURE TO FOLLOW INSTRUCTIONS.

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 TRANSGASTRIC TO THE PANCREAS TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) CYSTGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT FIRST FLANGE WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, IT GOT STUCK AND WOULD NOT PULL UPWARDS. 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. NOTE: IT WAS REPORTED THAT THE LUER LOCK FITTING ON THE AXIOS DEVICE DID NOT TWIST PROPERLY. THE HANDLE WAS ROTATED AS THE WINGNUT WAS NOT ATTACHING AND KEPT COMING LOOSE. THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE STATE "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE."