BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 3970598 · Received July 31, 2014

    Report

    Report Number
    2017233-2014-00393
    Event Type
    Death
    Date Received
    July 31, 2014
    Date of Event
    October 1, 2013
    Report Date
    November 26, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    LOT/SERIAL NUMBERS WERE NOT PROVIDED, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED; IT IS UNKNOWN IF THIS EVENT WAS PREVIOUSLY REPORTED. IF LOT/SERIAL NUMBERS ARE OBTAINED, THE REVIEW WILL BE INCLUDED ON THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED BY GORE BUT WAS NOT PROVIDED. THE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES: COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO: ENDOLEAK, DEATH.

    Description of Event or Problem · 1

    THIS ARTICLE REPORTS THAT ¿THE PROCEDURAL SUCCESS WAS DEFINED BY THE CORRECT EXCLUSION OF THE LESION WITHOUT ENDOLEAKS.¿ THE FURTHER REPORTS THAT ONE PATIENT EXPERIENCED A PROXIMAL TYPE I ENDOLEAK AFTER HAVING BEEN TREATED FOR AN AORTIC ARCH ANEURYSM USING A GORE® TAG® THORACIC ENDOPROSTHESIS. THE PATIENT REPORTEDLY EXPIRED ON POST-OPERATIVE DAY 1 AFTER EXPERIENCING AN ¿ANEURYSM RUPTURE IN FAILURE TEVAR.¿

    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 EXPERIENCED A TYPE IA ENDOLEAK AND EXPIRED ON DAY ONE POST-OP. THE CAUSE OF DEATH IS UNKNOWN DESPITE AUTOPSY. THE DATE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446605 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