BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5346717 · Received January 6, 2016

    Report

    Report Number
    2017233-2016-00024
    Event Type
    Injury
    Date Received
    January 6, 2016
    Date of Event
    December 18, 2009
    Report Date
    December 7, 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

    (B)(4): CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES - (B)(6) 2009: TG3420/7001154. (B)(6) 2009: TG4015/05974283, TG4020/06529998, TG4020/05730304. 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 AN UNKNOWN DATE IN 2008, THIS PATIENT UNDERWENT A TOTAL AORTIC ARCH REPLACEMENT USING A VASCULAR GRAFT. ON (B)(6) 2009, TWO GORE TAG THORACIC ENDOPROSTHESES (TG3115/7001115, TG3420/7001154) WERE IMPLANTED IN DESCENDING THORACIC AORTA. THE PREOPERATIVE ANEURYSM DIAMETER MEASURED 72 MM. ON (B)(6) 2009, THE PATIENT UNDERWENT A PLANNED ENDOVASCULAR PROCEDURE TO IMPLANT THREE GORETAG THORACIC ENDOPROSTHESES (TG4015/05974283, TG4020/06529998, TG4020/05730304). THE REASON FOR THIS PROCEDURE WAS NOT REPORTED. ON (B)(6) 2009, A TYPE II ENDOLEAK WAS IDENTIFIED. THE ANEURYSM DIAMETER MEASURED 70 MM. THE ORIGIN OF THE TYPE II ENDOLEAK WAS NOT REPORTED. ON (B)(6) 2010, THE PERSISTENT TYPE II ENDOLEAK WAS OBSERVED. THE ANEURYSM DIAMETER MEASURED 70 MM. ON (B)(6) 2010, THE PERSISTENT TYPE II ENDOLEAK WAS OBSERVED. THE ANEURYSM DIAMETER MEASURED 73 MM. ON (B)(6) 2011, THE PERSISTENT TYPE II ENDOLEAK WAS OBSERVED. THE ANEURYSM DIAMETER MEASURED 75 MM. ON (B)(6) 2012, THE PERSISTENT TYPE II ENDOLEAK WAS OBSERVED. THE ANEURYSM DIAMETER MEASURED 75 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7124 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7001115

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R