BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 11829333 · Received May 14, 2021

    Report

    Report Number
    2017233-2021-02007
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 22, 2021
    Report Date
    October 18, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED G3/G4 PMA NUMBER: P040043.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2006, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH A VALIANT® THORACIC STENT GRAFT PROXIMALLY. COVERAGE WAS EXTENDED DISTALLY WITH TWO GORE® TAG® THORACIC ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. THE ETIOLOGY OF THE TREATMENT WAS NOT UNKNOWN. . ON (B)(6) 2021, THE PATIENT UNDERWENT FOLLOW-UP IMAGING WHICH DETERMINED A PROXIMAL AND DISTAL TYPE I ENDOLEAK. THE IMAGES APPEAR TO IDENTIFY A 10CM PROXIMAL ANEURSYM AND A SUSPECTED DISTAL DISSECTION THOUGHT TO BE STENT INDUCED BY THE PHYSICIAN. THE PHYSICIAN PLANS TO RE-INTERVENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724770 GORE TAG THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other