BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2466894 · Received February 15, 2012

    Report

    Report Number
    2017233-2012-00092
    Event Type
    Death
    Date Received
    February 15, 2012
    Report Date
    January 9, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO ACQUIRE INFORMATION REQUIRED FOR THIS FORM WERE MADE BY GORE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE, OR WAS NOT APPLICABLE.

    Description of Event or Problem · 1

    IN REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED. MELISSA E. HOGG, MD, MARK D. MORASCH, MD, TAEYOUNG PARK, PHD, WALKER D. FLANNERY, BS, MICHAEL S. MAKAROUN, MD, AND JAE-SUNG CHO, MD, "LONG-TERM SAC BEHAVIOR AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR WITH THE EXCLUDER LOW-PERMEABILITY ENDOPROSTHESIS (ELPE)" COPYRIGHT 2011 BY THE SOCIETY FOR VASCULAR SURGERY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG425

    Patients

    Seq Age Sex Outcome Treatment
    1 Death