BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1882240 · Received October 21, 2010

    Report

    Report Number
    2953161-2010-00191
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    June 4, 2010
    Report Date
    October 20, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2005, THE PT WAS TREATED WITH GORE EXCLUDER AAA ENDOPROSTHESES FOR AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2010, THE PT PRESENTED WITH ABDOMINAL PAIN. A DISTAL TYPE I ENDOLEAK WAS IDENTIFIED IN AN AREA OF PROGRESSIVE ILIAC ARTERY EXPANSION. ON (B)(6) 2010, THE EXISTING DEVICE WAS EXTENDED WITH ANOTHER STENT-GRAFT TO TREAT THE TYPE I ENDOLEAK. COMPLETION ANGIOGRAPHY IDENTIFIED NO ENDOLEAK, AND THE PT TOLERATED THE PROCEDURE.

    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 WLG325 03438419

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R PXC181400/#(B)(4)