BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 912987 · Received September 12, 2007

    Report

    Report Number
    2953161-2007-00137
    Event Type
    Injury
    Date Received
    September 12, 2007
    Date of Event
    April 18, 2001
    Report Date
    September 11, 2007
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GORE EXCLUDER BIFURCATED ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT (PC261216/LOT#9820120-02) AND A GORE EXCLUDER BIFURCATED ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PC141400/LOT#9826005-05) WERE IMPLANTED. IN 2003, A GORE EXCLUDER BIFURCATED ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PC121200/LOT#02331094) WAS IMPLANTED.

    Description of Event or Problem · 1

    IN 1999, A GORE EXCLUDER BIFURCATED ENDOPROSTHESIS WAS IMPLANTED TO REPAIR AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. FOLLOW-UP IMAGES REVEALED ANEURYSMAL SAC GROWTH AND A DISTAL TYPE I ENDOLEAK. IN 2003, A GORE EXCLUDER BIFURCATED ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WAS IMPLANTED AND THE DISTAL TYPE I ENDOLEAK WAS SUCCESSFULLY REPAIRED. IT WAS REPORTED THAT THE PATIENT'S ANEURYSMAL SAC HAS CONTINUED TO INCREASE IN SIZE.

    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 982012002

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention