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 ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT WAS NOT CONFIRMED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING DOCUMENTATION REVIEW THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. IN ADDITION, THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISPOSED OF AT CUSTOMER SITE, PREVENTING EVALUATION OF THE DEVICE FOR ANY POTENTIAL DEFECT. WITHOUT THE ABILITY TO EXAMINE THE DEVICE, THE MOST PROBABLE CAUSE OF THE EVENT REMAINS 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 AS IT WAS DISPOSED OF AT CUSTOMER SITE; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. LABELING REVIEW: A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THERE IS NO INFORMATION THAT THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE (IFU)/ PRODUCT LABEL. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE HOT AXIOS DEVICE CONFIRMED THAT THE EVENT OF STENT FAILURE TO DEPLOY IS A KNOWN EVENT DEFINED IN THE PRODUCT'S RISK MANAGEMENT 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 TO BE IMPLANTED TRANSGASTRIC TO PANCREAS TO TREAT A PSEUDOCYST DURING AN AXIOS DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED AND THE AXIOS STENT DID NOT DEPLOY. THE STENT WAS REMOVED FULLY COVERED BY THE OUTER SHEATH, AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.