BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2151576 · Received June 29, 2011

    Report

    Report Number
    2017233-2011-00324
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    February 2, 2011
    Report Date
    June 28, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. IMAGES FOR THE EVENT ARE BEING ANALYZED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A TYPE B DISSECTION. ON (B)(6), 2011, IMAGES SHOWED A LACK OF WALL APPOSITION OF THE IMPLANTED TAG DEVICE DUE TO AN ANGULATED ARCH. ON (B)(6), 2011, AN ARCH REPLACEMENT WAS PERFORMED USING AN E-VITA OPEN PLUS HYBRID STENT GRAFT SYSTEM THAT WAS SUTURED TO THE PROXIMAL END OF THE TAG DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG426 06475038

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R