BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1812222 · Received August 20, 2010

    Report

    Report Number
    2017233-2010-00375
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    November 8, 2009
    Report Date
    August 19, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD- A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS- THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2005, THIS PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT, A CONTRALATERAL LEG COMPONENT, AND AN AORTIC EXTENDER COMPONENT. ON (B)(6), 2009, THE THREE GORE EXCLUDER AAA ENDOPROSTHESES WERE EXPLANTED. ON (B)(6), 2009, THE PATIENT EXPIRED DUE TO AN UNKNOWN CAUSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG325 03497344

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R