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: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CORPORATION COULD NOT CONFIRM THE REPORTED EVENT OF STENT FAILURE TO DEPLOY. THE CAUSE OF THE EVENT IS UNKNOWN. 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: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. HOWEVER, A MEDIA INSPECTION WAS CONDUCTED, WHICH SHOWED THE PRODUCT'S ORIGINAL POUCH AND LABEL, INCLUDING THE ASSOCIATED LOT NUMBER AND UPN, WITH NO VISIBLE EVIDENCE OF DAMAGE OR DEFECTS. 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 A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF 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 INTENDED FOR TRANSDUODENAL IMPLANTATION INTO THE PANCREAS TO FACILITATE DRAINAGE OF A LARGE PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, AFTER SUCCESSFUL ACCESS INTO THE CYST, THE FIRST FLANGE OF THE AXIOS STENT DID NOT DEPLOY. THE PHYSICIAN REPEATED THE DEPLOYMENT STEP WITH THE SAME OUTCOME. THE DEVICE WAS REMOVED FROM THE PATIENT, AND ATTEMPTS TO DEPLOY THE STENT OUTSIDE THE BODY SHOWED THAT IT REMAINED STUCK WITHIN THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.