BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1843518 · Received September 20, 2010

    Report

    Report Number
    2017233-2010-00407
    Event Type
    Death
    Date Received
    September 20, 2010
    Date of Event
    April 16, 2007
    Report Date
    September 17, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. RESULTS - THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS - AS STATED IN THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE TAG DEVICE MAY INCLUDE, BUT ARE NOT LIMITED TO, VASCULAR SPASM OR VASCULAR TRAUMA (E.G., ILIO-FEMORAL VESSEL DISSECTION, BLEEDING, RUPTURE), AND DEATH. ADDITIONAL DEVICE RELATED TO THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE PT WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESES. THE ILIAC ARTERY RUPTURED DURING THE PROCEDURE AND THE PT DIED. FURTHER INVESTIGATION IS IN PROCESS.

    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, INC WLG326 04621461

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R