AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 CONCLUDES THAT THE REPORTED EVENT INVOLVING FAILURE OF THE STENT TO DEPLOY COULD NOT BE CONFIRMED. THE DEVICE WAS NOT RETURNED, SO A TECHNICAL EVALUATION COULD NOT BE PERFORMED TO ASSESS FOR POTENTIAL DEFECTS. WITHOUT PROPER EVALUATION OF THE DEVICE, IT REMAINS UNKNOWN THE MOST PROBABLE CAUSE THAT CONTRIBUTED TO THE EVENT. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. HOWEVER, A SHIP HISTORY REVIEW WAS PERFORMED TO IDENTIFY THE MOST PROBABLE LOTS AND A MANUFACTURING REVIEW OF THE MOST PROBABLE LOTS DID NOT IDENTIFY ANY ANOMALIES OR DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE EVENT. DEVICE TECHNICAL ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. 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, BLEEDING IS NOTED WITHIN THE IFU AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE. RISK REVIEW: A REVIEW OF THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM DFMEA 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 THE AVAILABLE INFORMATION, THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION REGARDING THE CAUSE OF THE REPORTED EVENT. THEREFORE, THE MOST PROBABLE CAUSE ASSIGNED IS "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 TO BE IMPLANTED TRANSDUODENALLY INTO THE PANCREAS TO TREAT PANCREATIC WALLED-OFF NECROSIS (WON) DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE DELIVERY CATHETER WAS ADVANCED INTO THE COLLECTION, AND AN ATTEMPT WAS MADE TO DEPLOY THE FIRST FLANGE OF THE AXIOS STENT; HOWEVER, THE FLANGE DID NOT DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. REPORTEDLY, BLEEDING WAS NOTED AT THE PUNCTURE SITE AND RESOLVED ON ITS OWN. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION WAS DESCRIBED AS FULLY RECOVERED AT THE END OF THE PROCEDURE.