BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG ENDOPROSTHESIS

    MDR report key: 3076526 · Received April 22, 2013

    Report

    Report Number
    2017233-2013-00245
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    June 2, 2012
    Report Date
    March 25, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: TGT3110/9212598, TGU343410/9683448, AND TGU373710/7562177A.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS FOR TREATMENT OF AN ENLARGING DESCENDING THORACIC AORTIC ANEURYSM. ON (B)(6) 2012, THE PT PRESENTED WITH CHEST/BACK PAIN FOR ONE WEEK, AND A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A PROXIMAL TYPE I ENDOLEAK. IT WAS REPORTED THAT POORLY CONTROLLED HYPERTENSION AND PROGRESSIVE EXPANSION OF THE THORACIC AORTIC ANEURYSM (AMOUNT UNK), PARTICULARLY AT THE PROXIMAL SEAL ZONE OF THE ENDOGRAFT, CAUSED THE PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2012, A PROCEDURE WAS PERFORMED WHEREBY TWO CONFORMABLE GORE TAG THORACIC ENDOPROSTHESES WERE IMPLANTED TO TREAT THE ENDOLEAK. THE ENDOLEAK RESOLVED WITH THE IMPLANT OF THE ADDITIONAL DEVICES, AND THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2012, THE PT WAS BEING TREATED FOR BRUCELLOSIS, AND A CT OF THE CHEST SHOWED DEVELOPMENT OF A NEW PROXIMAL PSEUDOANEURYSM ABOVE THE PROXIMALLY IMPLANTED STENT GRAFT (DEVICE UNK). IT WAS REPORTED THE PSEUDOANEURYSM WAS MYCOTIC IN ORIGIN, RESULTING FROM THE BRUCELLOSIS. ON (B)(6) 2012, A PROCEDURE WAS PERFORMED WHEREBY AN ADDITIONAL CONFORMABLE GORE TAG DEVICE WAS IMPLANTED TO TREAT THE PSEUDOANEURYSM. THE IMPLANT OF THE ADDITIONAL DEVICE RESOLVED THE PSEUDOANEURYSM, AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170962 GORE TAG ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9212598

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R ALLOPURINOL| ATORVASTATIN| METOPROLOL| DOXYCYCLINE| ASPIRIN| WARFARIN| RIFAMPIN