BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5117212 · Received October 1, 2015

    Report

    Report Number
    2017233-2015-00668
    Event Type
    Injury
    Date Received
    October 1, 2015
    Date of Event
    January 14, 2011
    Report Date
    September 9, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    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

    ADDITIONAL MANUFACTURER NARRATIVE - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TGT3415/8518694, TGT4015/8233035). BEFORE IMPLANTING THE TAG® DEVICES, THE PATIENT UNDERWENT RIGHT AXILLARY ARTERY TO LEFT CAROTID ARTERY TO LEFT AXILLARY ARTERY BYPASS. THE PROXIMAL TAG® DEVICE (TGT3415/8518694) WAS IMPLANTED JUST BELOW THE BRACHIOCEPHALIC ARTERY. A CHIMNEY TECHNIQUE WITH A BARE-METAL STENT GRAFT WAS PERFORMED ON BRACHIOCEPHALIC ARTERY. AFTER DEPLOYMENT OF THE TAG® DEVICE, THE DEVICE MOVED PROXIMALLY AND COVERED THE BRACHIOCEPHALIC ARTERY. THE CHIMNEY BARE METAL STENT GRAFT DEVICE WAS NOT AFFECTED, BUT THE PHYSICIAN WAS CONCERNED ABOUT A POSSIBLE ENDOLEAK BETWEEN TAG® DEVICE AND CHIMNEY BARE METAL STENT GRAFT DEVICE. THEREFORE COIL EMBOLIZATION WAS PERFORMED BETWEEN THE TAG® DEVICE AND BARE METAL STENT GRAFT DEVICE. FINAL ANGIOGRAPHY SHOWED NOTHING ABNORMAL AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650823 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8518694

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R (B)(6) 2011: TGT4015/8233035