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 TRANSGASTRICALLY INTO THE PANCREAS TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE WITH AXIOS STENT PLACEMENT ON (B)(6) 2023. DURING THE PROCEDURE, THE DEVICE SUCCESSFULLY CAUTERIZED INTO THE CYST; HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE FIRST FLANGE, THE STENT WOULD NOT RELEASE. PULL-AND-PUSH TROUBLESHOOTING WAS ATTEMPTED, BUT THE FLANGE DID NOT OPEN. THE DEVICE WAS REMOVED, AND A SMALLER AXIOS STENT (15 MM) WAS USED, WHICH DEPLOYED WITHOUT PROBLEM. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. THE AXIOS STENT AND DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU.

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. IN ADDITION, THE MANUFACTURING DOCUMENTATION REVIEW DID NOT IDENTIFY ANY ISSUES THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. WITHOUT PROPER EVALUATION OF THE DEVICE, IT REMAINS UNKNOWN THE MOST PROBABLE CAUSE THAT CONTRIBUTED TO THE EVENT. 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. LABELING REVIEW: A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE/PRODUCT LABEL. THE IFU STATES: "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE." HOWEVER, IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. 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 INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION REGARDING THE CAUSE OF THE REPORTED EVENT. THEREFORE, THE MOST PROBABLE CAUSE ASSIGNED IS "CAUSE NOT ESTABLISHED."