BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1132138 · Received August 22, 2008

    Report

    Report Number
    2017233-2008-00513
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    May 26, 2006
    Report Date
    August 22, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.

    Description of Event or Problem · 1

    IN 2006, THIS PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK IPSILATERAL LEG COMPONENT (PXT261414/04114294) AND CONTRALATERAL LEG COMPONENT (PXC141000/04115436). AS REPORTED, THE PATIENT HAD A TYPE I ENDOLEAK AND IT WAS REPAIRED WITH AN EXTENSION AORTIC CUFF THE FOLLOWING MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES WLG325 04114294

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention