BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1140235 · Received August 29, 2008

    Report

    Report Number
    2017233-2008-00536
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 27, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    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 MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT UNDERWENT REPAIR OF THE DESCENDING PORTION OF THE TYPE A DISSECTION WITH THE GORE TAG THORACIC ENDOPROSTHESIS. AT AN UNKNOWN DATE, IMAGING DEMONSTRATED THAT THE PROXIMAL PORTION OF THE GORE TAG THORACIC ENDOPROSTHESIS HAD COLLAPSED. A PROXIMAL TYPE I ENDOLEAK WAS ALSO OBSERVED. TWO MONTHS LATER, THE PATIENT UNDERWENT A SUCCESSFUL REINTERVENTION IN WHICH A PALMAZ 3110 WAS IMPLANTED, RESOLVING THE COLLAPSE AND 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 ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES, INC WLG326 05155464

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention