BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1731057 · Received June 17, 2010

    Report

    Report Number
    2953161-2010-00113
    Event Type
    Death
    Date Received
    June 17, 2010
    Date of Event
    April 27, 2010
    Report Date
    June 16, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE HAS BEEN CONDUCTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL THE PRE-RELEASE SPECIFICATIONS. MYOCARDIAL INFARCTION. ADDITIONAL DEVICES RELATED TO THIS EVENT. PXC141200/7653532. THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES: ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: CARDIAC (E.G., ARRHYTHMIA, MYOCARDIAL INFARCTION, CONGESTIVE HEART FAILURE, HYPOTENSION OR HYPERTENSION).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE WELL. ON 05/25/2010, THE GORE FIELD SALES ASSOCIATE WAS MADE AWARE THAT THE PATIENT EXPIRED ON (B)(6) 2010. AN AUTOPSY WAS PERFORMED WHICH DETERMINED THE CAUSE OF DEATH TO BE AN ACUTE MYOCARDIAL INFARCTION. THE DEVICES REMAIN IN THE PATIENT. THE PHYSICIAN DOES NOT CONSIDER THE PATIENT'S DEATH TO BE DEVICE OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES WLG325 7169178

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death