BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROTHESIS

    MDR report key: 2820551 · Received October 25, 2012

    Report

    Report Number
    2017233-2012-00732
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    October 19, 2010
    Report Date
    October 1, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE STATES THAT POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENTS INCLUDE BUT ARE NOT LIMITED TO: NEUROLOGIC DAMAGE, LOCAL OR SYSTEMIC (E.G., STROKE).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PATIENT UNDERWENT A PROCEDURE USING A GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A THORACIC AORTIC DISSECTION. ON THE SAME DAY, THE PATIENT WAS DIAGNOSED WITH A CEREBRAL INFARCT, AND REHABILITATION WAS STARTED. ON (B)(6) 2010, THE PATIENT WAS RELEASED FROM THE HOSPITAL. A COMPLICATION (UNKNOWN) REMAINED AND THE REHABILITATION CONTINUED. AT THE ONE YEAR FOLLOW-UP EXAMINATION, THE PATIENT WAS STILL UNDER THE REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8138147

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| O