BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5164070 · Received October 21, 2015

    Report

    Report Number
    2017233-2015-00718
    Event Type
    Injury
    Date Received
    October 21, 2015
    Date of Event
    September 8, 2010
    Report Date
    October 1, 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) 2010, THIS PATIENT WAS IMPLANTED WITH A GORE® TAG® THORACIC ENDOPROSTHESES (TGT4020/8030666) TO TREAT A THORACIC AORTIC ANEURYSM. DURING THE PROCEDURE, A 'CHIMNEY GRAFT' TECHNIQUE FOR LEFT COMMON CAROTID ARTERY WAS PERFORMED. THE FINAL ANGIOGRAPHY SHOWED NO ENDOLEAKS. THE PATIENT TOLERATED THE PROCEDURE. AFTER THE PROCEDURE, THE PATIENT SUFFERED A STROKE. THE PATIENT UNDERWENT REHABILITATION FOR THE STROKE AT REGULAR INTERVALS. THE PROGNOSIS IS UNKNOWN. NO FURTHER INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695240 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8030666

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other