BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER®AAA ENDOPROSTHESIS

    MDR report key: 14831805 · Received June 27, 2022

    Report

    Report Number
    2017233-2022-03055
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    June 10, 2022
    Report Date
    October 27, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G3/G4: CORRECTED THE PMA/510(K)NUMBER FORM P040043 TO P020004.

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. A NON-GORE STENT GRAFT AND A CTAG (GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS OR A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM) WERE IMPLANTED IN THE DESCENDING AORTA, AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED ABOVE THE CELIAC ARTERY. A GORE® VIABAHN® ENDOPROSTHESIS WAS IMPLANTED IN THE CELIAC ARTERY. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED DUE TO FALSE LUMEN ENLARGEMENT. HOWEVER, NO NEW ENTRY TEARS WERE OBSERVED, AND NO BLOOD FLOW INTO THE FALSE LUMEN BETWEEN THE CTAG AND THE AORTIC EXTENDER ENDOPROSTHESIS WAS OBSERVED, BUT A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED BETWEEN CTAG AND THE AORTIC EXTENDER ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019096 GORE® EXCLUDER®AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention