BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 3761139 · Received April 21, 2014

    Report

    Report Number
    2017233-2014-00193
    Event Type
    Death
    Date Received
    April 21, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 24, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION DETERMINED THERE IS NO ALLEGATION AGAINST THE TAG3410/9910927 USED IN THIS PROCEDURE, WHEREBY THIS MEDWATCH SUBMITTED ON APRIL 19, 2014 IS HEREBY RETRACTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE AG THORACIC ENDOPROSTHESIS STATES, THE SAFETY AND EFFECTIVENESS OF THE GORE TAG THORACIC ENDOPROSTHESIS HAS NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: PENETRATING ULCERS, GENETIC CONNECTIVE TISSUE DISEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THIS PATIENT UNDERWENT TREATMENT FOR A PENETRATING AORTIC ULCER AND WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS, A GORE DRYSEAL SHEATH WAS USED FOR ADVANCEMENT. NO REPORTED ACCESS OR ADVANCEMENT ISSUES WERE ENCOUNTERED BY THE PHYSICIAN. INTRAOPERATIVELY, THE PATIENT SUFFERED A RUPTURE OF THE RIGHT EXTERNAL ILIAC ARTERY. THE RIGHT COMMON AND INTERNAL ILIAC ARTERIES WERE LIGATED AND A FEMORO-FEMORAL BYPASS WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. THERE WERE NO REPORTED ACCESS ISSUES. THE PHYSICIAN REPORTS THAT THE RUPTURED ILIAC ARTERY WAS CAUSED BY ATHEROSCLEROTIC DISEASE AND SYSTEMIC LUPUS ERIMATOSE. THE PATIENT WAS REPORTED TO HAVE SUFFERED 2000ML BLOOD LOSS. ON (B)(6) 2014, THE PATIENT DIED. THE CAUSE OF DEATH WAS REPORTED TO BE HYPOVOLEMIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241135 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9910927

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| O| R