BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1132139 · Received August 22, 2008

    Report

    Report Number
    2017233-2008-00516
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 22, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.

    Description of Event or Problem · 1

    AS REPORTED, IN 2008, THIS PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM WITH CALCIFIED PLAQUE IN BILATERAL ACCESS VESSELS IDENTIFIED PRIOR TO PROCEDURE. ACCESS VESSELS WERE WITHIN TREATMENT RANGE. THE PATIENT WAS TREATED WITH GORE EXCLUDER AAA ENDOPROSTHESES PXT231214/05840805 (RIGHT SIDE), AND PXC121200/06009039 (LEFT SIDE). THE FOLLOWING MONTH, PATIENT COMPLAINED OF DISCOMFORT IN RIGHT LEG. CT REVEALED SIGNIFICANT CALCIFIED PLAQUE DISTAL TO DEVICE IN RIGHT COMMON ILIAC ARTERY. PHYSICIAN REMOVED THE PLAQUE. THE NEXT DAY, PATIENT COMPLAINED OF NUMBNESS IN RIGHT LEG. THE FOLLOWING DAY, PHYSICIAN PERFORMED A FEMOROFEMORAL BYPASS. PATIENT TOLERATED THE PROCEDURE. DEVICES REMAIN IN PATIENT. PHYSICIAN SUSPECTS DEVICE RELATED ISSUE, BUT HAS NO CONFIRMATION. NO IMAGES ARE AVAILABLE. AS OF 2008, PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVACULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES WLG325 05840805

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention