BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD E-LUMINEX BILIARY STENT

    MDR report key: 7222009 · Received January 26, 2018

    Report

    Report Number
    7222009
    Event Type
    Death
    Date Received
    January 26, 2018
    Date of Event
    August 31, 2017
    Report Date
    August 31, 2017
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    FGE
    UDI-DI
    040495109010366
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING STENT PLACEMENT IN THE INFRA-RENAL ABDOMINAL ARTERY, AN AORTIC LEAK DEVELOPED. DESPITE AGGRESSIVE RESUSCITATION, PT EXPIRED AFTER BEING TRANSFERRED TO ANOTHER FACILITY FOR VASCULAR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65176 BARD E-LUMINEX BILIARY STENT BARE METAL BILIARY STENT FGE BARD PERIPHERAL VASCULAR, INC. ZBM1240 ANAV1634 040495109010366

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death