BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2953876 · Received February 4, 2013

    Report

    Report Number
    2017233-2013-00047
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    November 15, 2011
    Report Date
    January 14, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE ROOT CAUSE OF THE INTERVENTION IS UNKNOWN. ADDITIONAL DEVICE IMPLANTED AND INVOLVED IN THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESIS. ON (B)(6) 2011, A PROCEDURE WAS PERFORMED WHEREBY AN ADDITIONAL GORE TAG DEVICE WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45767 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8114779

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R