BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE INTRODUCER SHEATH

    MDR report key: 1696111 · Received May 18, 2010

    Report

    Report Number
    2017233-2010-00235
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 18, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K013282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT/SERIAL NUMBER WAS NOT AVAILABLE TO CONDUCT A MFG RECORDS REVIEW. A MFG RECORDS REVIEW WAS NOT CONDUCTED. THE GORE INTRODUCER SHEATH WAS ADVANCED INTO THE AORTA TO FACILITATE THE ENDOVASCULAR DELIVERY OF A GORE EXCLUDER AAA ENDOPROSTHESIS, WHICH NEVER CAME IN CONTACT WITH THE PT, HOWEVER, AS STATED IN THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, COMPLICATIONS 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), EMBOLIZATION (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA, AND DEATH.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE PT WAS BEING TREATED ELECTIVELY FOR A 7 CM INFRARENAL ABDOMINAL AORTIC ANEURYSM. A 12 FR GORE INTRODUCER SHEATH WAS ADVANCED THROUGH THE LEFT COMMON FEMORAL ARTERY BEYOND THE AORTIC BIFURCATION INTO THE AORTA. THE PT'S PRESSURE DROPPED SUDDENLY. THE ABDOMEN WAS OPENED TO FURTHER EXPLORE THE DROP IN PRESSURE. DESPITE NUMEROUS MEDICAL ATTEMPTS TO STABILIZE HIM, THE PT DIED. BLOOD LOSS WAS ESTIMATED AT ABOUT TWO LITERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE INTRODUCER SHEATH DYB/INTRODUCER, CATHETER DYB W.L. GORE & ASSOCIATES WLG345

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death AORTOGRAM| PLACEMENT OF BILATERAL RENAL STENTS (MFR UNK)| APPROX TWO WEEKS PRIOR TO THE PT'S DEATH