BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5117491 · Received October 1, 2015

    Report

    Report Number
    2017233-2015-00669
    Event Type
    Injury
    Date Received
    October 1, 2015
    Date of Event
    June 18, 2010
    Report Date
    September 9, 2015
    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

    ADDITIONAL MANUFACTURER NARRATIVE - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A THORACIC RUPTURED AORTIC ANEURYSM USING A TWO GORE® TAG® THORACIC ENDOPROSTHESES (TGT3415/7317774, TGT3415/7264553). ON (B)(6) 2010, AT A FOLLOW-UP STUDY, A DISTAL TYPE I ENDOLEAK WAS FOUND. AN ADDITIONAL GORE® TAG® THORACIC ENDOPROSTHESIS (TGT3115/7885120) WAS ADDITIONALLY IMPLANTED. FOLLOW-UP STUDIES WERE PERIODICALLY CONDUCTED. THE DISTAL TYPE I ENDOLEAK REMAINED. MEDICAL THERAPIES WERE TAKEN. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650464 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7317774

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R (B)(6)10:TGT3415/7264553 (B)(6) 10:TGT3115/7885120