BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2921944 · Received January 11, 2013

    Report

    Report Number
    2953161-2013-00009
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    June 27, 2012
    Report Date
    December 14, 2012
    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

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES IMPLANTED AND/OR RELATED TO THIS EVENT: PXC121200/7052556. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THIS PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2012, THIS PT UNDERWENT A REOPERATION TO REPAIR A TYPE II ENDOLEAK. THE PHYSICIAN PERFORMED A COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19248 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURSYM TREATMENT MIH W. L. GORE & ASSOCIATES 06505601

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention