BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 3973775 · Received August 1, 2014

    Report

    Report Number
    2017233-2014-00399
    Event Type
    Death
    Date Received
    August 1, 2014
    Date of Event
    October 1, 2013
    Report Date
    December 2, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ARTICLE MENTIONS THAT ONE PATIENT WAS TREATED FOR A TYPE B DISSECTION USING GORE® TAG® DEVICES. THE PATIENT WAS REPORTEDLY CONVERTED TO OPEN SURGICAL REPAIR OF THE ASCENDING AORTA AFTER PRESENTING WITH AN IATROGENIC RETROGRADE TYPE A DISSECTION. IT WAS REPORTED THE PATIENT LATER EXPIRED ON POST-OPERATIVE DAY 21 FROM CARDIAC TAMPONADE.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION, INCLUDING LOT/SERIAL NUMBER, WAS REQUESTED, HOWEVER NOT PROVIDED. THEREFORE, AN INVESTIGATION INTO THE CAUSE OF THIS EVENT COULD NOT BE PERFORMED AS WELL AS A REVIEW OF THE MANUFACTURING PAPERWORK COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IN A REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED. Y, GEORG, A. SCHWEIN, A. LEJAY, E. TARTAGLIA, E. GIRSOWICZ, J.G. KRETZ, F. THAVEAU, N. CHAKFE, DEPARTMENT OF VASCULAR SURGERY AND KIDNEY TRANSPLANTATION, NOUVEL HOPITAL CIVIL, STRASBOURG, FRANCE; PRACTICAL EXPERIENCE WITH THE TAG AND CONFORMABLE TAG DEVICES: LESSONS LEARNED IN ABOUT 100 CASES; OCTOBER 2013. THE AVERAGE AGE OF THE PATIENTS WAS 68 YEARS, AND THE MAJORITY OF THE PATIENTS WERE MALE. A TOTAL OF 96 PATIENTS WERE INCLUDED WHO WERE TREATED WITH GORE® TAG® THORACIC ENDOPROSTHESIS AND GORE® CONFORMABLE TAG® THORACIC ENDOPROSTHESIS IN A SINGLE INSTITUTION. ALL PATIENTS WERE TREATED BETWEEN JANUARY 2001 AND MARCH 2013. ALSO CONDUCTED WERE ANALYSES OF PATIENT DEMOGRAPHICS, PERIPROCEDURAL RECORDS, COMPLICATIONS, REINTERVENTIONS, AND SURVIVAL. AS THE ARTICLE WAS FIRST PUBLISHED ONLINE IN OCTOBER 2013, OCTOBER 1, 2013 WILL BE USED AS THE DATE OF EVENT. AS IT IS UNKNOWN WHAT VERSION OF GORE® TAG® THORACIC ENDOPROSTHESIS WAS USED, TAG® VERSION 1.5 WILL BE USED IN THE PRODUCT DESCRIPTION. THIS ARTICLE MENTIONS THAT ONE PATIENT WAS CONVERTED TO OPEN REPAIR OF THE ASCENDING AORTA AFTER TREATMENT OF FOR A RETROGRADE TYPE A DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450475 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| H| R