BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1080499 · Received July 22, 2008

    Report

    Report Number
    2017233-2008-00392
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 21, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED. PLEASE NOTE ATTACHED LIST OF ADD'L DEVICES IMPLANTED IN THIS PT.

    Description of Event or Problem · 1

    AS REPORTED, IN 2005, THIS PT PRESENTED WITH A THORACIC AORTIC ANEURYSM AND FOCAL DISSECTION, AND WAS TREATED WITH GORE EXCLUDER AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENTS AT THE LEVEL OF THE DIAPHRAGM. ON APPROX SEVEN MONTHS LATER, THE PT WAS ADMITTED FOR A PENETRATING ULCER AND SYMPTOMATIC ANEURYSM. THREE GORE TAG THORACIC ENDOPROSTHESES WERE IMPLANTED. A TYPE I ENDOLEAK WAS NOTED IN EARLY 2007, SECONDARY TO A CHEST INJURY. IN 2008, THE PT WAS CONVERTED TO OPEN SURGICAL REPAIR AND THE DEVICES WERE EXPLANTED AND DISCARDED. THE PT REPORTEDLY TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG326 03617467

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention