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, AS THE STENT WAS RETURNED FULLY DEPLOYED AND EXPANDED. THERE IS INSUFFICIENT EVIDENCE TO DETERMINE WHETHER THE STENT'S FAILURE TO DEPLOY RESULTED FROM THE PHYSICIAN'S DEVICE MANIPULATION DURING THE PROCEDURE OR FROM A DEVICE MALFUNCTION. 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. VISUAL INSPECTION CONFIRMED THAT THE STENT WAS FULLY EXTENDED AND DEPLOYED. THE DELIVERY SYSTEM WAS RETURNED IN POSITION 4, AND NO DAMAGE WAS OBSERVED ON EITHER THE STENT OR THE DELIVERY SYSTEM. LABELING REVIEW: A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE DIRECTIONS FOR USE (DFU). THE HOT AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF: A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH GREATER THAN OR EQUAL TO 70% FLUID CONTENT"; HOWEVER, IT WAS REPORTED THAT THE AXIOS STENT WAS USED TO TREAT A WALLED-OFF NECROSIS (WON) WITH LESS THAN 15% NECROTIC MATERIAL. 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 "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 TRANSGASTRICALLY INTO THE PANCREAS TO TREAT ACUTE PANCREATITIS WITH WALLED-OFF NECROSIS (WON) DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2023. REPORTEDLY, THE CYST CONTAINED LESS THAN 15% NECROTIC MATERIAL. DURING THE PROCEDURE, WHEN ATTEMPTING TO DEPLOY THE STENT, RESISTANCE WAS ENCOUNTERED AND THE DISTAL FLANGE DID NOT DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS USED TO TREAT A WALLED-OFF NECROSIS (WON) WITH LESS THAN 15% NECROTIC MATERIAL. HOWEVER, THE HOT AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF: A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH GREATER THAN OR EQUAL TO 70% FLUID CONTENT. THE USER DID NOT FOLLOW THE LABELED INDICATION.