BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS?

    MDR report key: 23889513 · Received December 24, 2025

    Report

    Report Number
    3005099803-2025-06888
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    November 30, 2025
    Report Date
    January 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QXH
    UDI-DI
    00191506008093
    PMA / PMN Number
    K233318
    Removal / Correction Number
    3005099803-12192025-004-
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN AT THIS TIME. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. BLOCK H7 AND H9: ADDED TYPE OF REMEDIAL ACTION AND THE CORRECTION/REMOVAL REPORTING # INFORMATION. BLOCK H11: THE BATCH INFORMATION WAS NOT PROVIDED FOR THIS EVENT, AND BSC CANNOT CONFIRM IF THE DEVICE USED IS WITHIN SCOPE OF THE RECALL. THIS EVENT WAS CONSERVATIVELY ASSOCIATED TO THE RECALL. 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. DESPITE MULTIPLE EFFORTS, BSC WAS UNABLE TO CONFIRM THE BATCH NUMBER FOR THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM USED IN THIS EVENT. BASED ON THE REPORTED CLINICAL OBSERVATIONS ASSOCIATED WITH FAILURE TO EXPAND AND THE DATE BSC WAS INFORMED OF THIS EVENT, BSC IS CONSERVATIVELY ASSOCIATING THIS EVENT WITH THE RECALL IN AN ABUNDANCE OF CAUTION. THE REFERENCED AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM MET ALL SPECIFICATIONS PRIOR TO FINAL APPROVAL FOR DISTRIBUTIONS/SALE.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED. IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF THE PROCEDURE WAS ABORTED. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF THE DEVICE USED TO TAMPONADE THE BLEEDING. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF THE PATIENT HOSPITALIZATION FOR TWO DAYS WHILE WAITING FOR THE NEW IMPLANT PROCEDURE. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF THE ENDOSCOPIC PROCEDURE TO GET THE NEW AXIOS STENT IMPLANTED 2 DAYS LATER.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED DURING A CHOLEDOCHO-DUODENOSTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE AXIOS DISTAL FLANGE WAS NOT OPENING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSDUODENAL TO THE GALLBLADDER FOR A GALLBLADDER DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6), 2025. DURING THE PROCEDURE, THE FIRST FLANGE WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, IT WAS NOT VISUALIZED UNDER EUS. MINOR HEMORRHAGE WAS OBSERVED THAT WAS TAMPONADE UNTIL IT STOPPED ON ITS OWN. THE CATHETER AND THE SCOPE WERE SUBSEQUENTLY RETRACTED FROM THE PATIENT TO OBSERVE THE STENT, AND IT WAS NOTICED THE FLANGE HAD NOT DEPLOYED. DEPLOYMENT WAS RE-ATTEMPTED OUTSIDE OF THE PATIENT TO SEE WHAT WAS HAPPENING WITH THE DEVICE, AND THE STENT COMPLETELY FLEW OUT OF THE CATHETER. THE PROCEDURE WAS ABORTED, AND A NEW AXIOS STENT WAS IMPLANTED 2 DAYS LATER TO LET THE PATIENT REST. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477045 AXIOS? GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM QXH BOSTON SCIENTIFIC CORPORATION M00553690 0037764852 00191506008093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R