BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 3842445 · Received June 2, 2014

    Report

    Report Number
    2017233-2014-00284
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    November 15, 2008
    Report Date
    May 26, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PATIENT WAS IMPLANTED WITH A GORE® TAG® THORACIC ENDOPROSTHESIS (TG3415/06375689) TO TREAT A SACCULAR THORACIC AORTIC ANEURYSM. SOME THROMBI WERE PRESENT IN THE BLOOD VESSEL. ON THE SAME DAY, THE PATIENT DEVELOPED PARAPLEGIA AND HE STARTED TO RECEIVE MEDICATION AND REHABILITATION TREATMENT. ON (B)(6) 2009, THE PATIENT WAS DISCHARGED AND TRANSFERRED TO ANOTHER HOSPITAL. PATIENT'S PARAPLEGIA CONDITION AT THE TIME OF DISCHARGE IS UNKNOWN. SINCE THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, HE WAS WITHDRAWN FROM THE FOLLOW-UP STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321070 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06375689

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R| S