BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS LD ILIAC / BILIARY

    MDR report key: 22804982 · Received August 14, 2025

    Report

    Report Number
    2124215-2025-55489
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 16, 2025
    Report Date
    August 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIO
    UDI-DI
    08714729392446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 CAME LOOSE FROM THE BALLOON. A 7.0X40X135 CM EXPRESS LD BALLOON STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS FOUND THAT STENT CAME LOOSE FROM THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1393209 EXPRESS LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC CORPORATION H74938047740130 0035932579 08714729392446

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown