BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3232271 · Received July 9, 2013

    Report

    Report Number
    2017233-2013-00441
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    January 11, 2013
    Report Date
    June 18, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICE IMPLANTED AND INVOLVED IN THIS EVENT: TGU373710/10486283.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT WAS IMPLANTED WITH TWO CONFORMABLE GORE TAG THORACIC ENDOPROSTHESES. ON (B)(6) 2013, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY A CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312696 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES, INC 10405290

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R