BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2471123 · Received February 22, 2012

    Report

    Report Number
    2017233-2012-00115
    Event Type
    Death
    Date Received
    February 22, 2012
    Date of Event
    October 28, 2011
    Report Date
    February 16, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO INCLUDING LOT NUMBERS WAS REQUESTED, BUT NOT PROVIDED. ACCORDING TO THE CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE THE CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS HAS NOT BEEN STUDIED IN PT POPULATIONS WITH A GENETIC CONNECTIVE TISSUE DISEASE (E.G. MARFANS AND EHLERS-DANLOS SYNDROME).

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE PT WAS IMPLANTED WITH THE CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A THORACIC AORTIC ULCER AND A MYCOTIC ANEURYSM. THE PT HAS HISTORY OF MARFAN'S DISEASE. POST OPERATIVE THE PT DEVELOPED AN AORTOESOPHAGEAL FISTULA AND EXPIRED ON (B)(6), 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC WLG426

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death (B)(4)