BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1063441 · Received June 19, 2008

    Report

    Report Number
    2953161-2008-00157
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 19, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    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 SPECIFICATIONS. TYPE II ENDOLEAK. PLEASE NOTE: GORE WAS AWARE OF THE EVENT IN 2008. HOWEVER, NEW INFO PROVIDED ON 06/18/2008 REVEALED THAT THE EVENT WAS MDR REPORTABLE. THEREFORE, THE DATE THAT GORE WAS AWARE WAS CHOSEN AS 06/18/2008 FOR THIS REPORT.

    Description of Event or Problem · 1

    IN 2008, A GORE EXCLUDER AAA ENDOPROSTHESIS WAS IMPLANTED TO REPAIR AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. ON THE SAME MONTH, A COMPUTED TOMOGRAPHY SCAN REVEALED THAT THE PT HAD A PROXIMAL TYPE I ENDOLEAK, TYPE II ENDOLEAK, AND ANEURYSM SAC ENLARGEMENT. THE PHYSICIAN PLANS TO PERFORM A REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 05652733

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other