BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5615880 · Received April 28, 2016

    Report

    Report Number
    2017233-2016-00414
    Event Type
    Injury
    Date Received
    April 28, 2016
    Date of Event
    January 17, 2011
    Report Date
    April 4, 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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4). USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING TWO GORE TAG THORACIC ENDOPROSTHESES (TGT3415/7910565 AT DISTAL, TGT4010/8130690 AT PROXIMAL) TO REPAIR A THORACIC AORTIC ANEURYSM WITH DIAMETER OF 64.8 MM. IT WAS REPORTED THAT THE PHYSICIAN PLANNED TO COVER LEFT COMMON CAROTID ARTERY AND LEFT SUBCLAVIAN ARTERY, SO RIGHT AXILLARY ARTERY-LEFT AXILLARY ARTERY AND LEFT COMMON CAROTID ARTERY BYPASS WAS MADE BEFORE THE PROCEDURE TO MAINTAIN BLOOD FLOW. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2011, THE PATIENT DEVELOPED PARAPLEGIA. STEROID PULSE THERAPY WAS PERFORMED TO TREAT THE PARAPLEGIA. ON (B)(6) 2011, FOLLOW-UP EXAMINATION SHOWED THE PARAPLEGIA REMAINED. A SLIGHT TYPE II ENDOLEAK (ORIGIN UNKNOWN) WAS ALSO REVEALED. A DIAMETER OF THE ANEURYSM WAS 52.5 MM. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. THE PATIENT DISCONTINUED FOLLOW-UP, SO NO FURTHER INFORMATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271181 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7910565

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other TGT4010/8130690