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 SUMMARY: BASED ON THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONFIRMED THE REPORTED EVENT OF STENT FAILURE TO DEPLOY BASED ON THE DESTRUCTIVE ANALYSIS OF THE DELIVERY SYSTEM WHICH FOUND THE OUTER SHEATH TWISTED, THE HANDLE WAS INCORRECTLY ROTATED AND DAMAGED THE DEVICE. DEVICE HISTORY RECORDS 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 EXAMINATION OF THE RETURNED DEVICE FOUND THE STENT FULLY COVERED AND UNDEPLOYED. THE DELIVERY SYSTEM WAS DISASSEMBLED DURING DESTRUCTIVE INSPECTION, AND THE OUTER SHEATH WAS FOUND TWISTED. NO OTHER PROBLEMS WERE NOTED WITH THE STENT AND DELIVERY SYSTEM. LABELING REVIEW: A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE IFU (INSTRUCTIONS FOR USE) / PRODUCT LABEL. THE PRODUCT INVESTIGATION FOUND THE OUTER SHEATH WAS RETUNED TWISTED WHICH IS EVIDENCE THE HANDLE WAS INCORRECTLY ROTATED, THE IFU STATES "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE." 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 A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF FAILURE TO FOLLOW INSTRUCTIONS.

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO AXIOS STENTS AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEMS USED DURING THE SAME PROCEDURE. REFER TO COMPLAINT (B)(4) FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A PSEUDOCYST DURING AN AXIOS DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE FIRST AXIOS STENT DID NOT DEPLOY. THE PHYSICIAN ATTEMPTED TO USE A SECOND STENT, WHICH HAD ENCOUNTERED THE SAME PROBLEM. A THIRD AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.