BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 4155863 · Received October 3, 2014

    Report

    Report Number
    MW5038522
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    EXPRESS LD ILIAC/BILIARY STENT
    Product Code
    NIO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STENT "HUNG UP" ON DISTAL END IN THE ILIAC ARTERY. STENT BECAME DISLODGED FROM THE BALLOON. ATTEMPTED TO ADVANCE A 6MMX40M BALLOON THROUGH STENT AND INFLATE TO CAPTURE STENT. STENT BECAME HUNG UP IN FEMORAL ARTERY. THIS REQUIRED OPEN RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617401 BOSTON SCIENTIFIC EXPRESS LD ILIAC/BILIARY STENT NIO EXPRESS LD ILIAC/BILIARY STENT H74938047940130 16145093

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R