BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS?

    MDR report key: 23649133 · Received November 25, 2025

    Report

    Report Number
    3005099803-2025-06400
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QXH
    UDI-DI
    08714729904588
    PMA / PMN Number
    K150692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE.

    Additional Manufacturer Narrative · 0

    BLOCK B5: UPDATED EVENT DESCRIPTION. BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE GALLBLADDER TO TREAT CHOLECYSTITIS THROUGH A GALLBLADDER DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER ENERGIZING AND PUNCTURING THE GALLBLADDER WITH THE CATHETER, DEPLOYMENT WAS ATTEMPTED BY OPERATING THE HANDLE. HOWEVER, IT APPEARED THE HANDLE WAS NOT PROPERLY LOCKED DURING THE GALLBLADDER-SIDE FLANGE DEPLOYMENT. THE PROCEDURE CONTINUED WITH DEPLOYMENT OF THE PROXIMAL FLANGE AND WHEN THE CATHETER WAS THEN PULLED BACK TOWARD THE DUODENAL SIDE, THE PROXIMAL FLANGE ALSO DEPLOYED, LEAVING THE IMPLANT INSIDE THE DUODENUM. THE PROCEDURE WAS COMPLETED BY PLACING A DIFFERENT DEVICE THROUGH THE SAME PUNCTURE SITE. THE ORIGINAL STENT REMAINS INSIDE THE PATIENT; HOWEVER, A PROCEDURE, SUCH AS REMOVAL, WILL BE PERFORMED LATER FOR THE AXIOS THAT REMAINS INSIDE THE PATIENT'S BODY. 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 INTENDED TO BE IMPLANTED IN THE GALLBLADDER TO TREAT CHOLECYSTITIS THROUGH GALLBLADDER DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AFTER ENERGIZING AND PUNCTURING THE GALLBLADDER WITH THE CATHETER, DEPLOYMENT WAS ATTEMPTED BY OPERATING THE HANDLE. HOWEVER, IT APPEARED THE HANDLE WAS NOT PROPERLY LOCKED DURING THE GALLBLADDER-SIDE FLANGE DEPLOYMENT. THE PROCEDURE CONTINUED WITH DEPLOYMENT OF THE PROXIMAL FLANGE AND WHEN THE CATHETER WAS THEN PULLED BACK TOWARD THE DUODENAL SIDE, THE PROXIMAL FLANGE ALSO DEPLOYED, LEAVING THE IMPLANT INSIDE THE DUODENUM. THE PROCEDURE WAS COMPLETED BY PLACING A DIFFERENT DEVICE THROUGH THE SAME PUNCTURE SITE. THE ORIGINAL STENT REMAINS INSIDE THE PATIENT; HOWEVER, A PROCEDURE, SUCH AS REMOVAL, WILL BE PERFORMED LATER FOR THE AXIOS THAT REMAINS INSIDE THE PATIENT'S BODY. NEW INFORMATION WAS RECEIVED INDICATION THAT THE STENT WAS LIKELY DEPLOYED WITHIN THE CHANNEL UPON REMOVAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569374 AXIOS? GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM QXH BOSTON SCIENTIFIC CORPORATION M00553640 0036791977 08714729904588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown