BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1841115 · Received September 17, 2010

    Report

    Report Number
    2953161-2010-00170
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 16, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    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

    METHOD - A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. CONCLUSIONS: AS STATED IN THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), THE SAFETY AND EFFECTIVENESS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN PATIENTS WITH PROXIMAL AORTIC NECK ANGULATIONS EXCEEDING 60 DEGREES.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE INFRARENAL AORTIC NECK LENGTH WAS FINE BUT THE AORTA WAS TORTUOUS, WITH A 70-DEGREE PROXIMAL NECK ANGLE. AFTER THE TRUNK-IPSILATERAL LEG COMPONENT WAS PLACED, THE PHYSICIAN ATTEMPTED TO CANNULATE THE CONTRA-GATE FOR NEARLY FORTY MINUTES BUT WAS UNABLE TO GET A WIRE THROUGH USING DIFFERENT APPROACHES. AN UNPLANNED AORTO-UNI-ILIAC (AUI) PROCEDURE WAS PERFORMED ALONG WITH A FEMORAL-TO-FEMORAL BYPASS. THE PT TOLERATED THE PROCEDURE WELL. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    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, INC. WLG325 7057964

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R