BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1132129 · Received August 21, 2008

    Report

    Report Number
    2017233-2008-00504
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 21, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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. PROXIMAL TYPE I ENDOLEAK.

    Description of Event or Problem · 1

    IN 2006, THIS PATIENT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS. IN 2008, IMAGING DEMONSTRATED A PROXIMAL TYPE I ENDOLEAK. THE FOLLOWING MONTH, THE PATIENT UNDERWENT A SUCCESSFUL REINTERVENTION IN WHICH ANOTHER GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED TO RESOLVE THE PROXIMAL TYPE I ENDOLEAK. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS ENDOVACULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES WLG326 04448003

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention