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 RESULT: WITH THE INFORMATION AVAILABLE, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT INVOLVING FAILURE OF THE STENT TO DEPLOY COULD NOT BE CONFIRMED. IN ADDITION, THE MANUFACTURING DOCUMENTATION REVIEW DID NOT IDENTIFY ANY ISSUES THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. 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: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. 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 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 DURING AN ENDOSCOPIC ULTRASOUND (EUS) PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.