BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1231924 · Received November 13, 2008

    Report

    Report Number
    2017233-2008-00868
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 14, 2008
    Report Date
    November 13, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS IS BEING CONDUCTED. ADDITIONAL DEVICES: PXC141400/06199608, PXC141000/06014342.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESIS. THE TRUNK-IPSILATERAL LEG COMPONENT WAS PLACED AS PLANNED, BUT DURING REPEATED ATTEMPTS TO CANNULATE THE CONTRA-LATERAL SIDE, A WIRE PERFORATED THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN DECIDED TO PERFORM AN AORTO-UNI-ILIAC PROCEDURE, AND ANOTHER TRUNK-IPSILATERAL LEG COMPONENT WAS PLACED ON THE IPSI-LATERAL SIDE. A CONTRALATERAL LEG COMPONENT WAS THEN PLACED TO OCCLUDE THE ILIAC PERFORATION, AND THE DEVICE COVERED THE LEFT INTERNAL ILIAC ARTERY. THE PROCEDURE WAS CONCLUDED WITH A FEM-FEM BYPASS, AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. FURTHER INVESTIGATION IS BEING CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES, INC WLG325 06027636

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| S