AXIOS?

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 RESULTS: WITH ALL AVAILABLE INFORMATION, BOSTON SCIENTIFIC CORPORATION CONCLUDES THAT THE REPORTED EVENT OF STENT FAILURE TO DEPLOY WAS ABLE TO BE CONFIRMED. THE DEVICE HAS BEEN RETURNED WITH THE STENT FULLY COVERED AND UNDEPLOYED. ADDITIONALLY, THE SHEATH WAS FOUND DETACHED IN THE HANDLE SECTION. MOST LIKELY PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, OR THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED) THAT COULD HAVE RESULTED IN THE DAMAGES ENCOUNTERED IN THE DEVICE, THESE DAMAGES COULD HAVE UNABLE TO DEPLOY THE STENT DURING THE PROCEDURE. DEVICE HISTORY RECORD (DHR) REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE TECHNICAL ANALYSIS: AN AXIOS STENT WITH ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS RECEIVED FOR ANALYSIS. IT WAS RETURNED WITH THE STENT FULLY COVERED AND UNDEPLOYED, HOWEVER THE DEPLOYMENT HUB WAS RETURNED IN POSITION 4. IN ADDITION, IT WAS NECESSARY TO DISASSEMBLE THE DELIVERY SYSTEM TO IDENTIFY ANY DAMAGE IN THE HANDLE SECTION OF THE DEVICE AND THE SHEATH WAS FOUND DETACHED (OUTER SHEATH). 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: TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE INTENDED TO BE IMPLANTED TRANSGASTRIC TO TREAT WALLED OFF NECROSIS (WON) DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DISTAL FLANGE FAILED TO DEPLOY. IT WAS ALSO REPORTED THAT SQUEEZING THE HANDLE WAS DIFFICULT AND THAT THE HANDLE BECAME JAMMED (SUBJECT OF THIS REPORT). THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE FIRST STENT AND INSERT ANOTHER OF THE SAME TYPE; HOWEVER, THE SAME ISSUE WAS REPORTED WITH THIS SECOND STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE OF THE SAME DEVICE (THIRD STENT). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.