BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1200648 · Received October 16, 2008

    Report

    Report Number
    2953161-2008-00309
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    October 2, 2007
    Report Date
    October 16, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ENDOLEAKS ARE A KNOWN RISK ASSOCIATED WITH THE DEVICE. ADDITIONAL DEVICES IMPLANTED IN PATIENT: PXC121400; PXC121000.

    Description of Event or Problem · 1

    IN 2007, THIS PATIENT WAS TREATED FOR A 3CM ABDOMINAL AORTIC ANEURYSM, A 5CM RIGHT COMMON ILIAC ANEURYSM, AND A 3CM LEFT COMMON ILIAC ARTERY ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. ON FIVE MONTHS LATER, THIS PATIENT PRESENTED WITH A TYPE I ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY DISTAL TO THE EXCLUDER DEVICE. A CONTRALATERAL LEG COMPONENT WAS IMPLANTED EXTENDING THE EXISTING DEVICE. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED PROCEDURE AND IS REPORTED TO BE STABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 04788848

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention