BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1201768 · Received October 15, 2008

    Report

    Report Number
    2017233-2008-00722
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    November 26, 2007
    Report Date
    October 14, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK FOR THE DEVICE VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. IT IS UNKNOWN WHICH DEVICE CAUSED THE TYPE I ENDOLEAK, THEREFORE, ALL FOUR GORE TAG THORACIC ENDOPROSTHESES WILL BE INVESTIGATED. ADDITIONAL DEVICES IMPLANTED ARE: TG3110/05427565, TG3710/05292447, AND TG4015/04582753.

    Description of Event or Problem · 1

    ON DECEMBER 21, 2007 GORE WAS MADE AWARE OF A PATIENT THAT WAS IMPLANTED WITH FOUR GORE TAG THORACIC ENDOPROSTHESIS AND A GORE EXCLUDER AAA ENDOPROSTHESIS IN 2007, TO TREAT A TYPE III THORACO-ABDOMINAL ANEURYSM. AT ABOUT TWO WEEKS LATER, THE PATIENT UNDERWENT A REINTERVENTION TO TREAT A PROXIMAL TYPE I ENDOLEAK USING A GORE TAG THORACIC ENDOPROSTHESIS. A SMALL TYPE II ENDOLEAK WAS IDENTIFIED ON CT SCANS DURING A FOLLOW-UP IN 2008, BUT THE PHYSICIAN DOES NOT PLAN ON TREATING THE PATIENT. THE PATIENT TOLERATED THE PROCEDURES, AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES,INC MLG326 04634934

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention