BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 6993271 · Received November 1, 2017

    Report

    Report Number
    2017233-2017-00575
    Event Type
    Death
    Date Received
    November 1, 2017
    Date of Event
    October 11, 2017
    Report Date
    October 11, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). CONCOMITANT PRODUCT(S): AS GORE WAS UNABLE TO DETERMINE WHICH DEVICE WAS INVOLVED IN THE EVENT IF ANY; ADDITIONAL DEVICE(S) IMPLANTED INCLUDE: TGU404020/15761281. PATIENT MEDICATIONS INCLUDE BUT ARE NOT LIMITED TO: ASPIRIN, CLONIDINE, COLACE, DOXAZOSIN, FERROUS SULFATE, FUROSEDMIDE, LEVOTHYROXINE, METOPROLOL TARTRATE, MYCOPHENOLATE MOFETIL NIFEDICAL XL, NITROGLYCERIN, OMEPRAZOLE, PLAVIX, PREDNISONE, PRAVASTATIN, PROCTO-MED HC, VICODIN, VITAMIN D3, XANAX A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE® TAG® THORACIC ENDOPROSTHESIS; ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO INCLUDE: DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE B THORACIC AORTIC DISSECTION WHICH ORIGINATED IN THE AORTIC ARCH (ZONE 2) AND EXTENDED DISTALLY TO THE FEMORAL ARTERY. THE PATIENT WAS IMPLANTED WITH TWO CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES USING A GORE® DRY SEAL FLEX INTRODUCER SHEATH (B)(4). IT WAS REPORTED THAT THE PATIENT EXPIRED INTRAPROCEDURE WITH THE CAUSE OF DEATH UNKNOWN, HOWEVER A POSSIBLE AORTIC RUPTURE IS SUSPECTED. NO AUTOPSY WILL BE PERFORMED. THERE WERE NO DEVICE OR SHEATH REPORTED DIFFICULTIES DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772889 CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 14875388A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death