BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1001910 · Received February 21, 2008

    Report

    Report Number
    2953161-2008-00029
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 25, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE SEE ATTACHED LIST OF ADDITIONAL DEVICES IMPLANTED IN THIS PATIENT: PCC141200/022211303, PCA230300/030651503.

    Description of Event or Problem · 1

    IN 2003, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. AN AORTIC EXTENDER COMPONENT WAS PLACED DISTAL TO THE TRUNK IPSILATERAL LEG COMPONENT IN THE PATIENT'S RIGHT ILIAC ARTERY. A REINTERVENTION TOOK PLACE IN 2008 TO RELINE THE GRAFTS DUE TO ENDOTENSION, AS WELL AS A POSSIBLE TYPE III ENDOLEAK BETWEEN THE TRUNK IPSILATERAL LEG COMPONENT AND THE AORTIC EXTENDER COMPONENT. GORE EXCLUDER AAA ENDOPROSTHESIS WERE IMPLANTED. THE PATIENT IS DOING FINE AND NO ENDOLEAKS WERE NOTED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W. L. GORE & ASSOCIATES, INC. WLG325 022033005

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention