BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4664720 · Received April 7, 2015

    Report

    Report Number
    2017233-2015-00211
    Event Type
    Injury
    Date Received
    April 7, 2015
    Date of Event
    November 15, 2010
    Report Date
    March 17, 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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TGT3420/7874994, PROXIMALLY, TGT3420/7160085, DISTALLY) TO REPAIR A THORACIC AORTIC ANEURYSM AT THE AORTIC ARCH. PRIOR TO THE DEVICE IMPLANT, BYPASS WAS ESTABLISHED FROM THE ASCENDING AORTA TO THE BRACHIOCEPHALIC, LEFT COMMON CAROTID, AND LEFT SUBCLAVIAN ARTERIES. IT WAS REPORTED THAT THE PATIENT LOST 580 ML OF BLOOD DURING THE WHOLE PROCEDURE. AFTER THE PROCEDURE, ON THE SAME DAY, THE PATIENT DID NOT AWAKEN. CT IMAGES REVEALED A BRAIN STEM INFARCTION, WHICH WAS TREATED WITH MEDICATION. THE CAUSE OF THE INFARCTION IS UNKNOWN. IT WAS REPORTED THAT THE INFARCTION DID NOT RESOLVE, AND THE PATIENT STAYED IN THE INTENSIVE CARE UNIT (ICU). ON AN UNKNOWN DAY IN (B)(6) 2011, THE PATIENT DEVELOPED PNEUMONIA AND WAS TREATED WITH ANTIBIOTICS. THE PNEUMONIA WAS REPORTEDLY NOT DEVICE OR PROCEDURE RELATED. ON (B)(6) 2011, THE PATIENT EXPIRED IN THE ICU DUE TO THE SEPSIS SUBSEQUENT TO THE PNEUMONIA. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227740 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7874994

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other 11/15/10: TGT3420/7160085