BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3221085 · Received July 3, 2013

    Report

    Report Number
    2017233-2013-00431
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 18, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN A REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: NAKAI M, SATO M, SATO H, SAKAGUCHI H, ET AL. MIDTERM RESULTS OF ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR: COMPARISON OF INSTRUCTION-FOR-USE (IFU) CASES AND NON-IFU CASES. JAPANESE JOURNAL OF RADIOLOGY. OF 124 PTS (104 MEN, 20 WOMEN; MEAN AGE 76.2 YEARS; AGE RANGE 58-93 YEARS) WITH AAA WHO UNDERWENT EVAR WITH THE ZENITH (68 PTS) OR EXCLUDER DEVICE (56) AND WERE ANALYZED, 86 WERE IFU AND 38 NON-IFU. THIS ARTICLE MENTIONS THAT 7 PTS HAD ANEURYSM ENLARGEMENT OF GREATER THAN OR EQUAL TO 5MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305098 GORE EXCLUDER AAA ENDOPROSTHESIS MIH - SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURSYM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other