BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2987597 · Received February 18, 2013

    Report

    Report Number
    2017233-2013-00080
    Event Type
    Injury
    Date Received
    February 18, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT/SERIAL NUMBER FOR THE DEVICE(S) ASSOCIATED WITH THIS ARTICLE IS NOT KNOWN. THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IN REVIEW OF PUBLISHED LITERATURE, THESE FINDING WERE NOTED. ARMANDO C. LOBATO, MD, PHD, AND LUCIANA CAMACHO-LOBATO, MD, PHD, SAO PAULO, BRAZIL, "THE SANDWICH TECHNIQUE TO TREAT COMPLEX AORTOILIAC OR ISOLATED ILIAC ANEURYSMS: RESULTS OF MIDTERM FOLLOW-UP" COPYRIGHT 2013 BY THE SOCIETY FOR VASCULAR SURGERY. BETWEEN OCTOBER 2008 AND MARCH 2011, A COHORT OF 40 PTS (95% MALE; MEAN AGE 72.2 YEARS) WAS FOLLOWED OVER A MEAN FOLLOW-UP PERIOD OF 12 +/- 4.4 MONTHS (RANGE: 6 - 30 MONTHS). THE ARTICLE DESCRIBES THAT ONE IPSILATERAL ILIAC LIMB STENT GRAFT THROMBOSIS OCCURRED 12 HOURS AFTER THE MAIN PROCEDURE. PATENCY WAS RESTORED WITH THROMBOEMBOLECTOMY FOLLOWED BY PLACEMENT OF A SELF-EXPANDABLE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70239 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention