AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAN AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRICALLY INTO THE PANCREAS TO FACILITATE DRAINAGE OF A PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE WITH AXIOS STENT PLACEMENT ON (B)(6) 2023. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED DURING THE ATTEMPTED DEPLOYMENT, AND NEITHER THE DISTAL NOR PROXIMAL FLANGE OF THE AXIOS STENT DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IMPROVED AFTER THE DRAINAGE. NOTE: IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER-LOCKED TO THE SCOPE. THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE STATE: "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE."

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 INFORMATION AVAILABLE, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED FAILURE OF THE STENT TO DEPLOY WAS CONFIRMED. THE CONTROL HUB WAS FOUND DETACHED FROM THE HANDLE, PREVENTING DEPLOYMENT OF THE STENT. THE REPORTED EVENT AND THE OBSERVED DAMAGE WERE MOST LIKELY ASSOCIATED WITH PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE SUCH AS LESION CHARACTERISTICS, DEVICE HANDLING, AND THE TECHNIQUE USED BY THE PHYSICIAN, INCLUDING THE FORCE APPLIED. THESE FACTORS MAY HAVE CONTRIBUTED TO THE DAMAGE OBSERVED IN THE DEVICE, WHICH IN TURN MAY HAVE PREVENTED SUCCESSFUL STENT DEPLOYMENT DURING THE PROCEDURE. 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 REMAINED FULLY COVERED AND UNDEPLOYED. THE CONTROL HUB WAS RETURNED DETACHED FROM THE HANDLE, AND THE DEVICE WAS RECEIVED WITH A SLIGHT SEPARATION AT THE NOSE CONE AND BLACK MARKER. A DESTRUCTIVE INSPECTION WAS PERFORMED TO ASSESS TORSIONAL DAMAGE, AND NO TWISTING OR DAMAGE TO THE SHEATH WAS IDENTIFIED. NO ADDITIONAL DAMAGE WAS OBSERVED ON 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 INSTRUCTIONS FOR USE/PRODUCT LABEL. THE IFU STATES: "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE." 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 MOST PROBABLE CAUSE ASSIGNED IS "ADVERSE EVENT RELATED TO PROCEDURE."