BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1201781 · Received October 15, 2008

    Report

    Report Number
    2017233-2008-00737
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    June 24, 2005
    Report Date
    October 14, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IN EARLY 2008, THIS PATIENT WAS RETROSPECTIVELY ENROLLED IN THE CLINICAL STUDY. IN 2005, THE PATIENT WAS IMPLANTED IN A GORE TAG THORACIC ENDOPROSTHESIS AND ON THE FOLLOWING MONTH, AN INDETERMINATE ENDOLEAK WAS REPORTED THAT HAS NOT BEEN RESOLVED. THE PATIENT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES,INC WLG326 03611849

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other