BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4120173 · Received September 25, 2014

    Report

    Report Number
    2017233-2014-00502
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    June 16, 2010
    Report Date
    August 29, 2014
    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

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.PER THE GORE® TAG® THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO ENDOLEAKS AND ANEURYSM EXPANSION.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES. THE PREOPERATIVE ANEURYSM DIAMETER MEASURED 71MM.ON (B)(6) 2009, THE PATIENT WAS DISCHARGED IN GOOD CONDITION. ON (B)(6) 2009, NO ENDOLEAK WAS IDENTIFIED. THE ANEURYSM DIAMETER MEASURED 69MM.ON (B)(6) 2010, A TYPE II ENDOLEAK ORIGINATING FROM AN INTERCOSTAL ARTERY. THE ANEURYSM DIAMETER INCREASED TO 75MM.ON (B)(6), 2011, ONE YEAR FOLLOW-UP IMAGES SHOWED THE PERSISTENT TYPE II ENDOLEAK AND A TYPE III ENDOLEAK FROM THE DEVICE JUNCTION. ON (B)(6) 2011, A GORE® TAG® THORACIC ENDOPROSTHESIS WAS IMPLANTED TO TREAT THE TYPE III ENDOLEAK. ON (B)(6) 2011, COIL EMBOLIZATION WAS PERFORMED TO TREAT THE TYPE II ENDOLEAK. ON (B)(6) 2012, FOLLOW-UP IMAGES SHOWED THE RESOLUTION OF THE TYPE II ENDOLEAK AND THE PERSISTENT TYPE III ENDOLEAK WHICH WAS LEFT TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599195 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06469195

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization ALSO IMPLANTED ON (B)(6) 2009: TG3115/06664274