BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1181677 · Received September 30, 2008

    Report

    Report Number
    2017233-2008-00682
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    December 6, 2006
    Report Date
    September 30, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IN 2006, THE PT WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS. A PROXIMAL TYPE 1 ENDOLEAK WAS NOTED (UNK DATE). THE FOLLOWING MONTH, THE PT WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS. THE ENDOLEAK WAS RESOLVED. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG326 04448027

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention