BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 4650675 · Received April 1, 2015

    Report

    Report Number
    2017233-2015-00201
    Event Type
    Injury
    Date Received
    April 1, 2015
    Date of Event
    June 14, 2011
    Report Date
    March 25, 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.USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU 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) 2009, THE PATIENT UNDERWENT AORTIC ARCH REPLACEMENT AND WAS IMPLANTED WITH A HAND-MADE Z STENT GRAFT IN AN OPEN THORACIC APPROACH. ON (B)(6), 2009, THE PATIENT WAS IMPLANTED WITH A GORE® TAG® THORACIC ENDOPROSTHESIS (TG3420/06561054) IN THE EXISTING Z STENT GRAFT TO TREAT A THORACIC AORTIC ANEURYSM. THE PROCEDURE WAS CONCLUDED WITHOUT ENDOLEAKS REVEALED. ON (B)(6) 2009, THE PATIENT WAS DISCHARGED OF THE HOSPITAL. ANEURYSM DIAMETER WAS 77MM, AND ENDOLEAKS AS WELL AS OTHER ADVERSE EVENTS HAD NOT BEEN PRESENT. ON (B)(6) 2010, IN SIX-MONTH FOLLOW-UP STUDY, ANEURYSM DIAMETER HAD SHRUNK TO 67MM. ENDOLEAKS AS WELL AS OTHER ADVERSE EVENTS HAD NOT BEEN REVEALED. ON (B)(6) 2010, IN ONE-YEAR FOLLOW-UP STUDY, ANEURYSM DIAMETER WAS 70MM. NO ENDOLEAKS HAD BEEN REVEALED. ON (B)(6) 2011, A FOLLOW-UP IMAGING REVEALED A TYPE III ENDOLEAK FROM THE JUNCTION BETWEEN THE TG3420 AND THE Z STENT GRAFT. ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH AN ADDITIONAL GORE® TAG® THORACIC ENDOPROSTHESIS (TGT3420/8895248) INSIDE THE JUNCTION TO TREAT THE TYPE III ENDOLEAK. ON (B)(6), 2011, IN TWO-YEAR FOLLOW-UP STUDY, IT WAS REVEALED THAT THE TYPE III ENDOLEAK HAD BEEN RESOLVED, BUT A TYPE II ENDOLEAK WAS NEWLY PRESENT. ANEURYSM DIAMETER HAD ENLARGED TO 79MM. ON (B)(6), 2012, THE PATIENT UNDERWENT COIL-EMBOLIZATION PROCEDURE TO TREAT THE TYPE II ENDOLEAK. ON (B)(6), 2012, IN THREE-YEAR FOLLOW-UP STUDY, THE TYPE II ENDOLEAK HAD BEEN PRESENT WITH ANEURYSM DIAMETER OF 80MM. ON (B)(6), 2013, IN FOUR-YEAR FOLLOW-UP STUDY, IT WAS REVEALED THAT THE TYPE II ENDOLEAK HAD STILL PERSISTED. A WAIT-AND-WATCH APPROACH HAD BEEN CONTINUED TO THE ENDOLEAK. IT WAS REPORTED THAT AS THE TAG DEVICE WAS IMPLANTED IN THE SELF-MADE Z STENT GRAFT, SEALING OF THE GRAFTS COULD BE INADEQUATE, CAUSING THE TYPE III ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214686 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06561054

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R TGT3420/8895248