BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1904043 · Received November 15, 2010

    Report

    Report Number
    2017233-2010-00506
    Event Type
    Death
    Date Received
    November 15, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 15, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK WAS CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. AS STATED IN THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE GORE TAG DEVICE PROVIDES ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA. COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE TAG DEVICE MAY INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK, REOPERATION, CARDIAC (E.G. ARRHYTHMIA, MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE, HYPOTENSION OR HYPERTENSION), VASCULAR SPASM OR VASCULAR TRAUMA (E.G. ILIO-FEMORAL VESSEL DISSECTION, BLEEDING, RUPTURE), AND DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PT WAS IMPLANTED WITH FOUR GORE TAG THORACIC ENDOPROSTHESES TO TREAT AN AORTIC ARCH ANEURYSM. THE PROCEDURE INCLUDED DE-BRANCHING OF VESSELS IN THE TRANSVERSE ARCH. ON (B)(6) 2010, A REINTERVENTION OCCURRED TO TREAT A DISTAL TYPE-1 ENDOLEAK AND A SUSPECTED TYPE-3 ENDOLEAK. A CONDUIT WAS BEING USED TO INTRODUCE A GORE TAG THORACIC ENDOPROSTHESIS; HOWEVER, THE RIGHT COMMON ILIAC ARTERY RUPTURED (BEFORE THE DEVICE ENTERED THE PT) AND BLOOD PRESSURE DROPPED. THE RUPTURE WAS REPAIRED, BUT TOTAL BLOOD LOSS EXCEEDED 1 LITER. THE GORE TAG DEVICE WAS IMPLANTED DURING ONGOING ATTEMPTS TO STABILIZE THE PT; HOWEVER, THE PT DIED INTRA-OPERATIVELY.

    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 WLG426 03879190

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H| L| R TG4020/(B)(4)| TG4020/(B)(4)| TGT4520/(B)(4)| TG4020/(B)(4)