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. 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. 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. 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 IN THE PANCREAS TO TREAT A PANCREATIC FLUID COLLECTION DURING AN ENDOSCOPIC ULTRASOUND (EUS) CYSTGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE FIRST FLANGE, RESISTANCE WAS ENCOUNTERED AND THE FLANGE WOULD NOT OPEN DESPITE MULTIPLE ATTEMPTS. TROUBLESHOOTING INCLUDED LOCKING AND UNLOCKING THE BOTTOM HUB AND REPEATEDLY PULLING THE TOP HUB, BUT THE STENT STILL DID NOT DEPLOY. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.