BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2415002 · Received January 6, 2012

    Report

    Report Number
    2017233-2012-00011
    Event Type
    Injury
    Date Received
    January 6, 2012
    Date of Event
    November 22, 2011
    Report Date
    December 19, 2011
    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

    RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF THE ANEURISMAL PROXIMAL SIDE OF THE HAND-MADE Z STENT GRAFT USING GORE TAG THORACIC ENDOPROSTHESIS. THE Z STENT GRAFT WAS IMPLANTED AT THE AORTIC ARCH TO TREAT THE ANEURYSM BY OPEN SURGERY SEVERAL YEARS AGO. TAG DEVICE (TGT3420/8790108) WAS IMPLANTED IN THE Z STENT GRAFT FROM THE PROXIMAL ANEURISMAL AORTA TO THE DESCENDING AORTA. ON (B)(6) 2011, THE CT SCAN OF THE PATIENT REVEALED THE DISTAL TYPE I ENDOLEAK WITH THE ANEURYSM ENLARGEMENT. ON (B)(6) 2011, ANOTHER STENT GRAFT (NON-GORE) WAS IMPLANTED TO REPAIR THE DISTAL TYPE I ENDOLEAK AT TGT3420. THE PATIENT TOLERATED THE PROCEDURE AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG426 8790108

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R