BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1254188 · Received December 5, 2008

    Report

    Report Number
    2953161-2008-00411
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    March 12, 2008
    Report Date
    December 4, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER - A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH THE GORE EXCLUDER AAA ENDOPROSTHESIS IN 2007 TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PT UNDERWENT A REINTERVENTION IN 2008 FOR AN UNSPECIFIED REASON. TWO AORTIC EXTENDER COMPONENTS WERE USED IN THIS PROCEDURE. THE FACILITY HAS ADVISED THAT NO INFO WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 04953219

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention