BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2253965 · Received September 14, 2011

    Report

    Report Number
    2953161-2011-00196
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    March 9, 2009
    Report Date
    September 13, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2008 THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2009, THE DEVICES WERE EXPLANTED. MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO ON THIS EVENT HAVE BEEN MADE BY GORE, HOWEVER, AS OF (B)(6), 2011, NO FURTHER INFO ON THIS PT HAS BEEN PROVIDED TO GORE.

    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 WLG425 05670359

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R (B)(4)