BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2250996 · Received September 12, 2011

    Report

    Report Number
    2953161-2011-00193
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 16, 2011
    Report Date
    September 13, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED. PLEASE NOTE ADDITIONAL DEVICES IMPLANTED AND RELATED TO THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNK DATE, A COMPUTED TOMOGRAPHY REVEALED A TYPE III ENDOLEAK FROM THE TRUNK-IPSILATERAL LEG COMPONENT AND THE AORTIC EXTENDER COMPONENT. ON AN UNK DATE, THE TYPE III ENDOLEAK WAS TREATED USING A MEDTRONIC GRAFT. ON AN UNK DATE, A TYPE III ENDOLEAK WAS REVEALED FROM THE AORTIC EXTENDER COMPONENT AND THE MEDTRONIC DEVICE. ON (B)(6) 2011, THE AORTIC EXTENDER COMPONENT AND MEDTRONIC DEVICE WERE EXPLANTED DUE TO THE ENDOLEAK. THE REMAINING TWO GORE EXCLUDER AAA ENDOPROSTHESIS REMAINED INSIDE THE PT. 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 WLG425 04364882

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R