BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 21541078 · Received March 6, 2025

    Report

    Report Number
    2124215-2025-12275
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729392279
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STENT FELL OFF THE BALLOON PRIOR TO DEPLOYMENT. AN 8.0MM X 40MM X 75CM EXPRESS LD PREMOUNTED STENT SYSTEM WAS ADVANCED FOR USE IN THE STENOSED SUBCLAVIAN ARTERY. IT WAS THEN DECIDED TO REMOVE THE DEVICE AND PREDILATE AGAIN. UPON REMOVAL OF THE DEVICE, IT WAS OBSERVED THAT THE STENT HAD FALLEN OFF THE BALLOON IN THE SUBCLAVIAN ARTERY. A 4.0 X 40 MM BALLOON WAS ABLE TO BE THREADED INTO THE STENT, AND THE STENT WAS DEPLOYED IN THE RADIAL ARTERY. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799933 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938046840750 0032646065 08714729392279

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention