BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS

    MDR report key: 11004187 · Received December 14, 2020

    Report

    Report Number
    2017233-2020-01523
    Event Type
    Injury
    Date Received
    December 14, 2020
    Date of Event
    November 18, 2020
    Report Date
    April 1, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132617739
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G3/4: PMA/510(K) NUMBER CORRECTED TO P040043.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE PATIENT WAS TREATED FOR A THORACIC AORTIC ANEURYSM. THREE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES WERE IMPLANTED. NO FURTHER INFORMATION WAS AVAILABLE. ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. NO INFORMATION IS AVAILABLE FOR THE CAUSE OF THE IMPLANT. ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS. IT WAS USED TO PROXIMALLY EXTEND ONE OF THE PREVIOUSLY IMPLANTED DEVICES. THERE WAS NO INFORMATION AVAILABLE ON THE REASON THE DEVICE WAS IMPLANTED. THE PHYSICIAN STATED THAT THERE WAS DISEASE PROGRESSION. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465876 CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. TGU404010 00733132617739

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention