BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2575125 · Received May 9, 2012

    Report

    Report Number
    2017233-2012-00308
    Event Type
    Death
    Date Received
    May 9, 2012
    Date of Event
    April 11, 2012
    Report Date
    April 12, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING GORE TAG THORACIC ENDOPROSTHESIS. A TAG DEVICE WAS IMPLANTED AT THE DESCENDING AORTA. AND NO ENDOLEAK WAS OBSERVED. ON (B)(6) 2012, FOLLOW UP CTA REVEALED AORTIC DISSECTION AT THE ASCENDING AORTA WHICH WAS FROM THE ORIGIN OF THE CORONARY ARTERY. FROM THE IMAGES BEFORE THE IMPLANTATION OF THE TAG, THE PHYSICIAN FOUND THAT THERE HAD BEEN THE DISSECTION BEFORE THE PROCEDURE. AND HE HAD NOT BEEN AWARE OF IT. THE PHYSICIAN DECIDED TO PERFORM THE ASCENDING AORTIC REPLACEMENT WITH THE VASCULAR GRAFT AND WOULD SCHEDULE SURGERY TO TREAT THE DISSECTION. ON (B)(6) 2012, THE PT EXPIRED DUE TO THE AORTA RUPTURE FROM THE DISSECTION.

    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 9282030

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death