BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 1201540 · Received October 17, 2008

    Report

    Report Number
    2017233-2008-00759
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    May 12, 2008
    Report Date
    October 17, 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 DIABETES WAS IMPLANTED WITH A GORE PROPATEN VASCULAR GRAFT IN AN A-V ACCESS PROCEDURE. IN 2008, THE PT PRESENTED WITH A RUPTURED ANEURYSM OF AN UNK LOCATION. A GORE-TEX STRETCH VASCULAR GRAFT AND A VIABAHN ENDOPROSTHESIS WAS USED TO REPAIR THE ANEURYSM. AT ABOUT ONE MONTH LATER, THE PT PRESENTED WITH THROMBOSIS, AND A PTA PROCEDURE WAS PERFORMED. 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 1861622055

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention