BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT

    MDR report key: 842214 · Received April 27, 2007

    Report

    Report Number
    842214
    Event Type
    Death
    Date Received
    April 27, 2007
    Date of Event
    April 11, 2007
    Report Date
    April 26, 2007
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROSTAR XL CLOSURE DEVICE DEPLOYED, LIFE-THREATENING RETROPERITONEAL HEMORRAHAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT PROSTAR XL CLOSURE DEVICE MGB ABBOTT VASCULAR PROSTAR XL 123-22-01 50019-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death ENDOVASCULAR STENT GRAFT DEVICE| ANEURX AAA ADVANTAGE BIFURCATION (LONG)| ANEURX AAA ADVANTAGE ILIAC LIMB (MEDIUM)