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 DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DISTAL FLANGE DID NOT OPEN WITHIN THE COLLECTION. THE DEVICE WAS CHANGED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

Additional Manufacturer Narrative

BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY.

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 DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DISTAL FLANGE DID NOT OPEN WITHIN THE COLLECTION. THE DEVICE WAS CHANGED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

Additional Manufacturer Narrative

BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY. BLOCK H11: INVESTIGATION SUMMARY: WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CORPORATION CONCLUDES THAT THE REPORTED EVENT OF STENT FAILURE TO DEPLOY COULD NOT BE CONFIRMED. HOWEVER, THE STENT WAS RETURNED IN A PARTIALLY DEPLOYED CONDITION. STENT PARTIALLY DEPLOYED IS NOTED WITHIN THE INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. DURING FUNCTIONAL INSPECTION, THE STENT COULD NOT BE FULLY EXPANDED UNTIL IT WAS PLACED IN A WARM WATER BATH. THE INVESTIGATION CONCLUDED THAT STENT EXPANSION RATES MAY BE AFFECTED BY FACTORS SUCH AS COMPRESSION, TIME, TEMPERATURE, AND HUMIDITY. SLOWER EXPANSION IS MORE COMMONLY OBSERVED IN LARGER STENT SIZES DUE TO THE GREATER DEGREE OF COMPRESSION WITHIN THE CATHETER DELIVERY SYSTEM. AS STENT DIAMETER INCREASES, THE STENT IS PACKED MORE TIGHTLY, WHICH CAN INFLUENCE EXPANSION BEHAVIOR FOLLOWING RELEASE. ALTHOUGH LARGER DIAMETERS TYPICALLY REQUIRE GREATER COMPRESSION, ALL STENT SIZES MAY EXHIBIT VARIABILITY DEPENDING ON THE DEGREE OF COMPRESSION DURING LOADING. HIGHER COMPRESSION CAN TEMPORARILY REDUCE THE UNCONSTRAINED OPENING DIMENSIONS COMPARED TO MANUFACTURING SPECIFICATIONS, RESULTING IN SLOWER INITIAL EXPANSION UNTIL THE STENT REACHES ITS INTENDED SHAPE. 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 RETURNED FOR EVALUATION IN A PARTIALLY DEPLOYED CONDITION. VISUAL INSPECTION CONFIRMED THAT STENT DEPLOYMENT HAD BEEN INITIATED, AS THE DELIVERY HANDLE WAS POSITIONED IN THE SECOND STAGE OF DEPLOYMENT AND THE DISTAL FLANGE WAS FULLY EXPANDED. X-RAY IMAGING INDICATED THAT THE PROXIMAL PORTION OF THE STENT WAS LOCATED NEAR THE RADIOPAQUE MARKER, SUGGESTING PROXIMAL MIGRATION OF THE STENT RELATIVE TO THE SHEATH DURING THE PROCEDURE. DURING FUNCTIONAL EVALUATION, THE STENT DEPLOYED WITHOUT RESISTANCE UPON RETRACTION OF THE SLIDER; HOWEVER, THE PROXIMAL FLANGE AND SADDLE DID NOT FULLY EXPAND AS INTENDED. NO EVIDENCE OF BRAID DEFORMATION, INCLUDING TWISTS OR FOLDS, WAS OBSERVED. HEAVY PROCEDURAL RESIDUE WAS PRESENT ON BOTH THE STENT AND INNER SHEATH, CONSISTENT WITH IN-PROCEDURE USE CONDITIONS. FOLLOWING IMMERSION IN A WARM WATER BATH, THE PROXIMAL END DEMONSTRATED PARTIAL EXPANSION BUT DID NOT ACHIEVE ITS INTENDED FINAL CONFIGURATION. NO ADDITIONAL DEVICE-RELATED ABNORMALITIES WERE IDENTIFIED DURING ANALYSIS. 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. ADDITIONALLY, STENT PARTIALLY DEPLOYED IS NOTED WITHIN THE IFU AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE REPORTED 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 CAUSE LINKED TO DEVICE BUT UNABLE TO TRACE MORE SPECIFICALLY. BOSTON SCIENTIFIC IS INITIATING A REMOVAL OF CERTAIN SIZES OF THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM (6MM X 8MM, 8MM X 8MM AND 20MM X 10MM) MANUFACTURED SINCE MARCH 1, 2025. THIS ACTION IS BEING TAKEN DUE TO INCREASED REPORTS OF STENT DEPLOYMENT AND EXPANSION ISSUES WITH THESE CONFIGURATIONS. THESE ISSUES ONLY OCCUR AT THE TIME OF STENT DELIVERY AND ARE EXPECTED TO BE NOTICED BY THE PHYSICIAN. PATIENTS WHO HAVE BEEN TREATED WITH A SUCCESSFULLY IMPLANTED AXIOS STENT SHOULD CONTINUE TO FOLLOW STANDARD OF CARE AND ARE NOT AFFECTED BY THIS ISSUE. A LETTER WAS SENT OUT TO MATERIALS MANAGERS/HEALTH CARE PROFESSIONALS ON 19-DEC-2025 TO IMMEDIATELY STOP FURTHER DISTRIBUTION OR USE OF ANY AFFECTED 6MM X 8MM, 8MM X 8MM AND 20MM X 10MM AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM. THE LETTER INDICATES TO REMOVE THESE DEVICES FROM INVENTORY AND SEGREGATE THEM IN A SECURE LOCATION UNTIL THEY CAN BE RETURNED TO BOSTON SCIENTIFIC. THE REFERENCED AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM MET ALL SPECIFICATIONS PRIOR TO FINAL APPROVAL FOR DISTRIBUTIONS/SALE.

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 DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DISTAL FLANGE DID NOT OPEN WITHIN THE COLLECTION. THE DEVICE WAS CHANGED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

Additional Manufacturer Narrative

BLOCK H7 (IF REMEDIAL ACT INIT, TYPE), H9 AND H11 WERE UPDATED. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY. BLOCK H11: BOSTON SCIENTIFIC IS INITIATING A REMOVAL OF CERTAIN SIZES OF THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM (6MM X 8MM, 8MM X 8MM AND 20MM X 10MM) MANUFACTURED SINCE MARCH 1, 2025. THIS ACTION IS BEING TAKEN DUE TO INCREASED REPORTS OF STENT DEPLOYMENT AND EXPANSION ISSUES WITH THESE CONFIGURATIONS. THESE ISSUES ONLY OCCUR AT THE TIME OF STENT DELIVERY AND ARE EXPECTED TO BE NOTICED BY THE PHYSICIAN. PATIENTS WHO HAVE BEEN TREATED WITH A SUCCESSFULLY IMPLANTED AXIOS STENT SHOULD CONTINUE TO FOLLOW STANDARD OF CARE AND ARE NOT AFFECTED BY THIS ISSUE. A LETTER WAS SENT OUT TO MATERIALS MANAGERS/HEALTH CARE PROFESSIONALS ON 19-DEC-2025 TO IMMEDIATELY STOP FURTHER DISTRIBUTION OR USE OF ANY AFFECTED 6MM X 8MM, 8MM X 8MM AND 20MM X 10MM AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM. THE LETTER INDICATES TO REMOVE THESE DEVICES FROM INVENTORY AND SEGREGATE THEM IN A SECURE LOCATION UNTIL THEY CAN BE RETURNED TO BOSTON SCIENTIFIC. THE REFERENCED AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM MET ALL SPECIFICATIONS PRIOR TO FINAL APPROVAL FOR DISTRIBUTIONS/SALE.