BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 978059 · Received January 11, 2008

    Report

    Report Number
    2953161-2007-00216
    Event Type
    Injury
    Date Received
    January 11, 2008
    Date of Event
    December 17, 2007
    Report Date
    January 10, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. ALSO IMPLANTED IN THE PT (PXC/LOT#05133655, AND PXL161007/LOT#05159429).

    Description of Event or Problem · 1

    AS REPORTED, IN 2007, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO REPAIR AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. SIX DAYS LATER, TOMOGRAPHY REVEALED A DISTAL INFOLDING OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE FOLLOWING DAY, THE PT UNDERWENT A REINTERVENTION IN WHICH A STENT WAS IMPLANTED AND THE INFOLDING WAS SUCCESSFULLY REPAIRED. THE PT WAS DISCHARGED AND HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W. L. GORE & ASSOCIATES, INC. WLG325 05014607

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention