BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 23478445 · Received November 5, 2025

    Report

    Report Number
    2124215-2025-79292
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729392095
    PMA / PMN Number
    K133110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K): K133110, P090003.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. A 10.0X40X75CM EXPRESS LD STENT BALLOON EXPANDING WAS SELECTED FOR USE. POST IMPLANTATION, IT WAS NOTED THAT THERE WAS RESISTANCE ENCOUNTERED AND THE BALLOON SEGMENT OF THE CATHETER BECAME DISCONNECTED. THE DISCONNECTED PORTION HAD REMAINED PARTIALLY WITHIN THE SHEATH; THEREFORE, THE SHEATH AND THE BROKEN CATHETER SEGMENT WERE ABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2692902 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938046104070 0031215094 08714729392095

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown