BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2032598 · Received March 23, 2011

    Report

    Report Number
    2017233-2011-00146
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 22, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE GORE TAG THORACIC ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN PT ETIOLOGIES INCLUDING PENETRATING ULCERS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THIS PT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS. ON (B)(6) 2011, THIS PT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A PENETRATING ULCER THAT PROGRESSED INTO A SACCULAR ANEURYSM APPROX 7-8 MM PROXIMAL TO THE ORIGINAL GORE TAG DEVICE. THE PT TOLERATED THE PROCEDURE.

    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 06141511

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R