BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5617486 · Received April 28, 2016

    Report

    Report Number
    2017233-2016-00417
    Event Type
    Injury
    Date Received
    April 28, 2016
    Date of Event
    August 11, 2009
    Report Date
    April 4, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2009, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING A GORETAGTHORACIC ENDOPROSTHESES (PROXIMAL: TG3115/06683029, DISTAL: TG3415 /06690585) FOR A THORACIC AORTIC ANEURYSM REPAIR. AFTER THE PROCEDURE, A DISTAL TYPE I ENDOLEAK WAS IDENTIFIED. THE ANEURYSM DIAMETER WAS 57 MM. ON (B)(6) 2009, THE PATIENT WAS DISCHARGED. THE DISTAL TYPE I ENDOLEAK REMAINED. ON (B)(6) 2009, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING A GORETAGTHORACIC ENDOPROSTHESIS (TG3415/06822710) FOR THE DISTAL TYPE I ENDOLEAK REPAIR. ON (B)(6) 2010, IN ONE-YEAR FOLLOW-UP STUDY, THE DISTAL TYPE I ENDOLEAK REMAINED. THE ANEURYSM DIAMETER WAS 51 MM. ON (B)(6) 2010, THE PATIENT UNDERWENT AN ADDITIONAL ENDOVASCULAR PROCEDURE USING A GORE TAGTHORACIC ENDOPROSTHESIS (TGT3415/7791971) FOR THE DISTAL TYPE I ENDOLEAK REPAIR. ON (B)(6) 2010, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN, ALTHOUGH IT WAS REPORTED TO BE NOT DUE TO ANEURYSM RUPTURE. NO FURTHER INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273380 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06690585

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R