BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 1201379 · Received October 17, 2008

    Report

    Report Number
    2017233-2008-00755
    Event Type
    Death
    Date Received
    October 17, 2008
    Date of Event
    March 25, 2007
    Report Date
    October 16, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2007, A FEMALE WITH A HISTORY OF RENAL FAILURE AND HYPERTENSION WAS IMPLANTED WITH A GORE PROPATEN VASCULAR GRAFT IN AN A-V ACCESS PROCEDURE. PT EXPIRED ON THE FOLLOWING MONTH OF UNKNOWN CAUSES. THERE WAS NO ALLEGATION OF PRODUCT DEFICIENCY MADE BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE PROPATEN VASCULAR GRAFT NONE DSY W.L. GORE & ASSOCIATES WLG450 1861784036

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death