BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1270674 · Received December 18, 2008

    Report

    Report Number
    2953161-2008-00425
    Event Type
    Injury
    Date Received
    December 18, 2008
    Date of Event
    August 1, 2008
    Report Date
    December 17, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS IS BEING CONDUCTED.

    Description of Event or Problem · 1

    IN 2008, THE PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PROCEDURE WENT AS PLANNED. THREE MONTHS LATER, THE PT UNDERWENT A SECOND PROCEDURE TO ADDRESS A 2-3 CM SEPARATION BETWEEN THE LEFT SIDE CONTRALATERAL PXC141200 AND PXL161407 DEVICES. A PXC141200 WAS PLACED TO BRIDGE THE TWO DEVICES. THE TYPE III ENDOLEAK RESOLVED, AND THE PT IS STABLE WITH NO FURTHER COMPLICATIONS. THE GRAFT SEPARATION WAS ATTRIBUTED TO EXTERNAL ILIAC TORTUOSITY AND INSUFFICIENT OVERLAP BETWEEN THE PXC AND PXL DEVICES AT THE INITIAL PLACEMENT. 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 05489672

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention