BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 2143656 · Received January 13, 2006

    Report

    Report Number
    2017233-2006-00007
    Event Type
    Injury
    Date Received
    January 13, 2006
    Date of Event
    December 15, 2005
    Report Date
    January 13, 2006
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LEFT IMPLANTED IN PT. THE INVESTIGATION IS CURRENTLY IS PROCESS.

    Description of Event or Problem · 1

    THE PT PRESENTED A VERY TORTIOUS AORTA. DURING A GORE EXCLUDER BIFURCATED ENDOPROSTHESIS PROCEDURE, A TRUNK IPSILATERAL DEVICE WAS SUCCESSFULLY DEPLOYED BELOW THE RENAL ARTERIES. AFTER SOME DIFFICULTY CANNULATING THE CONTRALATERAL GATE, THE CLINICIAN SUCCESSFULLY DEPLOYED THE DEVICE. A COMPLETION ANGIOGRAM REVEALED AN OCCLUSION OF THE LEFT RENAL ARTERY. THE CLINICIAN BELIEVED THE CONTRALATERAL CANNULATION DIFFICULTY MAY HAVE CAUSED THE TRUNK IPSILATERAL DEVICE TO MOVE PROXIMALLY, THUS OCCLUDING THE LEFT RENAL ARTERY. A STENT WAS SUCCESSFULLY DEPLOYED IN THE LEFT RENAL ARTERY TO MAINTAIN FLOW TO THE ARTERY. THE REMAINDER OF THE PROCEDURE WAS WITHOUT INCIDENT. THE PT'S CONDITION WAS STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER BIFURCATED ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES, INC. WLG325 03945613

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention