AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

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 WALLED-OFF NECROSIS (WON) DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT DID NOT OPEN AT ANY POINT, AND RESISTANCE WAS ENCOUNTERED DURING DEPLOYMENT ATTEMPTS. THE DEVICE WAS REMOVED FROM THE PATIENT FULLY COVERED, INDICATING THAT NO PORTION OF THE STENT DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER EUS SCOPE AND ANOTHER AXIOS STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE OKAY.

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. THE DEVICE WAS RETURNED; HOWEVER, DURING FUNCTIONAL EVALUATION, THE STENT WAS ABLE TO BE DEPLOYED WITHOUT DIFFICULTY. IN ADDITION, NO DAMAGE WAS OBSERVED ON THE STENT OR THE DELIVERY SYSTEM. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. DEVICE TECHNICAL ANALYSIS: AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS RECEIVED FOR ANALYSIS. A VISUAL INSPECTION WAS PERFORMED AND CONFIRMED THAT THE STENT WAS FULLY COVERED AND UNDEPLOYED, AND NO DAMAGE WAS OBSERVED ON THE DELIVERY SYSTEM. A FUNCTIONAL EVALUATION WAS THEN CONDUCTED. THE CATHETER WAS UNLOCKED BY SLIDING THE CATHETER LOCK TO THE RIGHT, AFTER WHICH THE CATHETER CONTROL HUB WAS MOVED UP AND DOWN. THE CATHETER PASSED THROUGH THE LUER WITHOUT RESISTANCE. THE STENT HUB WAS THEN MOVED TO THE SECOND AND FOURTH POSITIONS. THE CATHETER MOVED FREELY, NO ISSUES WERE NOTED, AND THE STENT DEPLOYED WITHOUT RESISTANCE OR DIFFICULTY. LABELING REVIEW: A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL. 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 MOST PROBABLE CAUSE ASSIGNED IS "NO PROBLEM DETECTED."