BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1192411 · Received October 7, 2008

    Report

    Report Number
    2017233-2008-00711
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 2, 2008
    Report Date
    October 7, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICE IMPLANTED AND RELATED TO THIS EVENT: TG4040.

    Description of Event or Problem · 1

    OPERATIVE NOTES STATE THAT IN 2008, THE PT PRESENTED WITH A RUPTURED THORACIC ANEURYSM AND WAS TREATED WITH TWO GORE TAG THORACIC ENDOPROSTHESES; A 34MM X 15CM DEVICE PROXIMALLY AND A 40MM X 20 CM DEVICE DISTALLY (IT IS NOTED THAT THE OPERATIVE NOTES STATE THAT ONLY ONE 40 X 20 DEVICE WAS USED, AND MEDICAL DEVICE TRACKING, STATES THAT TWO 40 X 20 DEVICES WERE IMPLANTED). A CARDIOMEMS DEVICE WAS ALSO IMPLANTED WITHIN THE ANEURYSM SAC. DURING THE FIRST POST OPERATIVE VISIT ON THE SAME DAY, A DISTAL TYPE I ENDOLEAK WAS NOTICED AND TWO 40MM X 10CM GORE TAG THORACIC ENDOPROSTHESES WERE IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG326 05803384

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention