BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1872080 · Received October 12, 2010

    Report

    Report Number
    2017233-2010-00448
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    May 5, 2006
    Report Date
    October 11, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE DEVICE HAVE BEEN CONDUCTED. A REVIEW OF THE MFG RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. ENDOLEAK. ADDITIONAL DEVICES RELATED TO THIS EVENT ARE: TG4020/03621090. THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES: COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE TAG THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO; ENDOLEAK.

    Description of Event or Problem · 1

    ON (B)(6) 2006, THE PT UNDERWENT TREATMENT FOR A THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE TAG THORACIC ENDOPROSTHESIS. THE PT TOLERATED THE PROCEDURE WITH NO EVIDENCE OF ENDOLEAK. ON (B)(6) 2006, A COMPUTED TOMOGRAPHY (CT) SCAN DETECTED A LARGE AREA OF ENDOLEAK IN THE ANEURYSM SAC. TYPE 1 ENDOLEAK BOTH DISTALLY AND PROXIMALLY AND A SUSPECTED TYPE 3 ENDOLEAK AT THE DISTAL END. ADDITIONAL GORE TAG THORACIC ENDOPROSTHESIS WERE PLACED WITHIN THE PREVIOUSLY IMPLANTED GRAFTS TO EXTEND COVERAGE. ANGIOGRAPHY SHOWED A HIGH GRADE DISSECTION AND STENOSIS OF THE RIGHT COMMON ILIAC ARTERY WHICH MAY HAVE OCCURRED DURING TRANSPORTATION OF THE ENDOLUMINAL GRAFT. AN ABSOLUTE STENT WAS PLACED IN THE RIGHT EXTERNAL ILIAC ARTERY, A LUMINEX WAS DEPLOYED TO THE RIGHT COMMON ILIAC ARTERY, WITH AN EXPRESS STENT PLACED IN THE RIGHT COMMON ILIAC ARTERY. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES WLG326 03682172

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R