BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3415252 · Received October 4, 2013

    Report

    Report Number
    2017233-2013-00650
    Event Type
    Injury
    Date Received
    October 4, 2013
    Date of Event
    June 14, 2013
    Report Date
    September 25, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN REVIEW OF PUBLISHED LITERATURE, THE FINDINGS WERE NOTED: CHARLES J. KEITH JR, BA, MARC A. PASSMAN, MD, MICHAEL J. GAFFUD, MD, ZDENEK NOVAK, MD, MSHI, BENJAMIN J. PEARCE, MD, THOMAS C MATTHEWS, MD, MARK A. PATTERSON, MD, AND WILLIAM D. JORDAN JR, MD, "COMPARISON OF LONG-TERM OUTCOMES FOLLOWING ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS BASED ON SIZE THRESHOLD". COPYRIGHT 2013 BY THE SOCIETY FOR VASCULAR SURGERY. FROM JANUARY 2000 THROUGH DECEMBER 2011, 740 PATIENTS UNDERWENT ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS AT THE UNIVERSITY OF ALABAMA-BIRMINGHAM UNIVERSITY HOSPITAL, 383 (51.8%) OF WHOM WERE IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES. THE MEAN AGE RANGED FROM 69.3 TO 73.6 YEARS. MORE THAN HALF OF THE PATIENTS WERE MALE. THE ARTICLE DESCRIBES THAT ARTERIAL PERFORATION/RUPTURE WAS NOTED IN THREE PATIENTS. THE ARTICLE DID NOT INDICATE WHICH EVENTS, IF ANY, INVOLVED EXCLUDER DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504138 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other