BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1770204 · Received July 21, 2010

    Report

    Report Number
    2017233-2010-00341
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 20, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THIS PT WAS TREATED WITH HYBRID ARCH RECONSTRUCTION DURING AN ELEPHANT TRUNK PROCEDURE UTILIZING A GORE TAG THORACIC ENDOPROSTHESIS AND BOSTON SCIENTIFIC 32MM HEMASHIELD ELEPHANT TRUNK DEVICE. ON (B)(6) 2010, CTA CONFIRMED THE PRESENCE OF A SYMPTOMATIC TYPE II ENDOLEAK. THE PT WAS ALSO COMPLAINING OF BACK PAIN. THE FILMS HAVE BEEN FORWARDED TO IMAGING SERVICES. THE PT IS SCHEDULED FOR A F/U AORTOGRAM. ON (B)(6) 2010, AN ADD'L PROCEDURE WAS PERFORMED WHEREBY A LARGE INTERCOSTAL ARTERY AND THE ANEURYSM SAC WERE SUCCESSFULLY COIL EMBOLIZED. COMPLETION ANGIOGRAPHY REVEALED NO FURTHER ENDOLEAK AND THE PATIENTS BACK PAIN LESSENED. A F/U CAT SCAN WILL BE PERFORMED IN TWO WEEKS.

    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 05593984

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O| R