BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1053354 · Received May 28, 2008

    Report

    Report Number
    2953161-2008-00124
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    February 4, 2008
    Report Date
    May 27, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    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. PLEASE NOTE ATTACHED LIST OF ADDITIONAL DEVICES IMPLANTED IN PATIENT: PXC121200/04251410 AND PXL161207/042261104.

    Description of Event or Problem · 1

    IN LATE 2004, THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT, CONTRALATERAL LEG COMPONENT, AND AN ILIAC EXTENDER COMPONENT. IN 2008, DEVICES WERE EXPLANTED DUE TO ANEURYSM ENLARGEMENT RELATED TO A TYPE II ENDOLEAK FROM A LUMBAR ARTERY THAT COULD NOT BE TREATED WITH INTERVENTIONAL TECHNIQUES. THE PATIENT WAS CONVERTED TO OPEN REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 042050310

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention