BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1081681 · Received July 24, 2008

    Report

    Report Number
    2017233-2008-00408
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, THIS PT WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A TYPE B DISSECTION. THE FOLLOWING DAY, CONTRAST-ENHANCED COMPUTED TOMOGRAPHY SCANNING REVEALED A TYPE A DISSECTION WITH AN INTIMAL TEAR ADJACENT TO THE PROXIMAL DEVICE. THE PT UNDERWENT OPEN SURGICAL REPAIR OF THE TYPE A DISSECTION. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention