BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TAG® THORACIC ENDOPROSTHESIS

    MDR report key: 5640448 · Received May 9, 2016

    Report

    Report Number
    2017233-2016-00447
    Event Type
    Injury
    Date Received
    May 9, 2016
    Date of Event
    December 22, 2009
    Report Date
    April 11, 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

    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) 2009, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF AN AORTIC ARCH ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TG3420/7244641, TG4020/7001208.) PRIOR TO THE IMPLANTATION, A DEBRANCHING SURGERY WAS PERFORMED ON THE AORTIC ARCH BRANCHES, AND A CORONARY ARTERY BYPASS GRAFTING WAS ALSO PERFORMED. THE PREOPERATIVE ANEURYSM DIAMETER MEASURED 76 MM. ON (B)(6) 2009, THE PATIENT SUFFERED HEART FAILURE DUE TO AORTIC REGURGITATION CAUSED BY A TYPE A DISSECTION. ON THE SAME DAY, AN ASCENDING AORTA REPLACEMENT AND AN AORTIC VALVE REPLACEMENT WERE PERFORMED TO TREAT THE AORTIC REGURGITATION AND THE TYPE A DISSECTION. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, THE PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A DESCENDING THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® THORACIC ENDOPROSTHESES (TG3415/7306625, TG3420/05626826). IT WAS REPORTED AS A GUIDEWIRE WAS INSERTED THROUGH THE PATIENT¿S TORTUOUS ANATOMY, AN ANEURYSM RUPTURE OCCURRED. THE TAG DEVICES WERE IMPLANTED AS PLANNED AND THE BLEEDING WAS UNDER CONTROL. HOWEVER, THE CIRCULATION COLLAPSED AND THE PATIENT DID NOT RECOVER. THE PATIENT EXPIRED ON THE SAME DAY DUE TO THE ANEURYSM RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297446 GORE® TAG® THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 7244641

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R (B)(6) 2009: TG4020/7001208