BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2430291 · Received January 20, 2012

    Report

    Report Number
    2017233-2012-00035
    Event Type
    Death
    Date Received
    January 20, 2012
    Report Date
    January 9, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT/SERIAL NUMBERS AND ADD'L INFO REGARDING THESE EVENTS HAVE BEEN REQUESTED. PLEASE NOTE THE ARTICLE IS ATTACHED TO THE MEDWATCH REPORT. ADD'L INFO ABOUT SPECIFIC PTS, DEVICES, AND EVENTS IS NOT AVAILABLE THEREFORE GORE CANNOT DETERMINE IF ANY OF THESE EVENTS WERE PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    AN ARTICLE PUBLISHED BY THE CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE REVIEWED THE "TEN YEARS OF EXPERIENCE WITH THE GORE EXCLUDER STENT-GRAFT FOR THE TREATMENT OF AORTIC AND ILIAC ANEURYSMS: OUTCOMES FROM A SINGLE CENTER STUDY" (DR. MALEUX, ET AL, PUBLISHED ON AUGUST 6, 2011). BETWEEN (B)(6) 1998 AND (B)(6) 2010, A TOTAL OF 121 NONCONSECUTIVE PTS WERE SELECTED FOR GORE EXCLUDER STENT-GRAFT IMPLANTATION AT THE UNIVERSITY HOSPITALS OF (B)(6). THE GROUP OF PHYSICIANS DISCUSSED IN THIS ARTICLE THE FOLLOWING ADVERSE EVENTS, COMPLICATIONS AND REINTERVENTIONS: PROXIMAL/DISTAL TYPE I ENDOLEAKS, LIMB THROMBOSIS, LIMB KINKING, PROXIMAL STENT-GRAFT INFOLDING, STENT-GRAFT INFECTION, TYPE II ENDOLEAKS, GROIN PSEUDOANEURYSM, ENDOTENSION AND DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES,INC WLG325

    Patients

    Seq Age Sex Outcome Treatment
    1 Death