BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3231971 · Received July 3, 2013

    Report

    Report Number
    2017233-2013-00428
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    November 30, 2008
    Report Date
    June 13, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    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 MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF ANEURYSMS OF THE AORTIC ARCH AND DESCENDING AORTA USING TWO GORE TAG THORACIC ENDOPROSTHESIS AND TWO NON-GORE MANUFACTURED (NAJUTA) STENT GRAFTS. A TG4020/05974288 WAS IMPLANTED PROXIMAL, AND A TG3715/05974244 WAS IMPLANTED DISTAL. THE PREOPERATIVE DESCENDING AORTIC ANEURYSM SIZE WAS 90MM. THE TWO NAJUTA STENT GRAFTS WERE IMPLANTED TO REPAIR THE ANEURYSM OF THE AORTIC ARCH AND THE TWO TAG DEVICES WERE IMPLANTED DISTALLY TO REPAIR THE DESCENDING AORTIC ANEURYSM. THE TWO ANEURYSMS WERE SEPARATED, BUT THE NAJUTA AND TAG DEVICES OVERLAPPED. THE FINAL ANGIOGRAPHY SHOWED NO ENDOLEAK. ON (B)(6) 2008, FOLLOW UP EXAM IDENTIFIED A TYPE III DISCONNECT ENDOLEAK. HOWEVER, IT COULD NOT BE DETERMINED IF THE ENDOLEAK WAS FROM THE NAJUTA STENT GRAFTS OR THE TAG DEVICES. THE PHYSICIAN DETERMINED TO MONITOR THE PATIENT CLOSELY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL NEXT DAY. ON (B)(6) 2008, THREE MONTH FOLLOW UP EXAMINATION CONFIRMED THE TYPE III ENDOLEAK REMAINED. THE ANEURYSM HAD NOT INCREASED IN SIZE. ON (B)(6) 2008, AN INTERVENTION OCCURRED WHEREBY A NON-GORE MANUFACTURED STENT GRAFT WAS IMPLANTED TO REPAIR THE TYPE 3 ENDOLEAK. THE FINAL ANGIOGRAPHY SHOWED THE RESOLUTION OF THE ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303751 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC 05974288

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R TG3715/05974244