BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2992838 · Received February 27, 2013

    Report

    Report Number
    2017233-2013-00096
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    August 31, 2012
    Report Date
    January 30, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES TO TREAT A THORACIC AORTIC ANEURYSM. A PROXIMAL TYPE I ENDO LEAK WAS PRESENT AFTER THE PROCEDURE. ON (B)(6) 2011, THE PT WAS IMPLANTED WITH AN ADDITIONAL GORE TAG THORACIC ENDOPROSTHESIS TO TREAT THE TYPE I ENDOLEAK. THE ENDOLEAK WAS RESOLVED AND THE PT TOLERATED THE PROCEDURE. ON (B)(6) 2012, THE PT WAS IMPLANTED WITH A CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS TO TREAT AN UNKNOWN CONDITION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84158 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC 8601697

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other PREDNISONE| ALBUTEROL| FUROSEMIDE| GLIMEPIRIDE| HYDRALAZINE| WARFARIN