BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5523805 · Received March 24, 2016

    Report

    Report Number
    2017233-2016-00282
    Event Type
    Injury
    Date Received
    March 24, 2016
    Date of Event
    November 8, 2010
    Report Date
    March 9, 2016
    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

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A THORACIC AORTIC ANEURYSM USING TWO GORE TAG THORACIC ENDOPROSTHESES (TGT3415/8178342, TGT4015/8093196). PRIOR TO THE DEVICE IMPLANT ON THE SAME DAY, A BYPASS SURGERY WAS PERFORMED FROM THE RIGHT AXILLARY ARTERY TO THE LEFT COMMON CAROTID AND LEFT AXILLARY ARTERIES. A STENT GRAFT (DETAIL UNKNOWN) WAS IMPLANTED IN THE BRACHIOCEPHALIC ARTERY AS CHIMNEY TECHNIQUE. A TYPE II ENDOLEAK FROM THE LEFT SUBCLAVIAN ARTERY WAS OBSERVED DURING THE PROCEDURE; HOWEVER THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, A COIL EMBOLIZATION PROCEDURE TO THE LEFT SUBCLAVIAN ARTERY WAS PERFORMED TO REPAIR THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. ON (B)(6) 2011, A FOLLOW-UP IMAGING SHOWED THAT THE DIAMETER OF THE ANEURYSM WAS 55.5 MM. THE ENDOLEAK WAS REPORTEDLY RESOLVED, AND NO ISSUES WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179392 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8178342

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R (B)(6) 2010: TGT4015/8093196