BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE DRYSEAL SHEATH

    MDR report key: 2632504 · Received June 22, 2012

    Report

    Report Number
    3007284313-2012-00012
    Event Type
    Death
    Date Received
    June 22, 2012
    Date of Event
    May 29, 2012
    Report Date
    June 5, 2012
    Manufacturer
    W. L. GORE ASSOCIATES
    Product Code
    DYB
    PMA / PMN Number
    K093791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. ADD'L SHEATH: 9971293/SDV1828.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT COMPLAINED OF BELLY PAIN AND A COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED AN ABDOMINAL AORTIC ANEURYSM AS WELL AS BILATERAL ILIAC ANEURYSMS. ON (B)(6) 2012, THE PT UNDERWENT REPAIR OF THE ABDOMINAL AORTIC ANEURYSM AND BILATERAL ILIAC ANEURYSMS AND WAS IMPLANTED WITH FIVE GORE EXCLUDER AAA ENDOPROSTHESES. THE PT TOLERATED THE PROCEDURE. ALL ARTERIES APPEARED FINE ON THE FINAL ANGIO. ON (B)(6) 2012, AFTER THE PROCEDURE, THE PT WENT INTO HYPOVOLEMIC SHOCK AND UNDERWENT AN EXPLORATORY LAPAROTOMY. THE PT'S LEFT ILIAC ARTERY WAS RUPTURED. THE PT EXPIRED DUE TO THE RUPTURED ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE DRYSEAL SHEATH DYB/INTRODUCER, CATHETER DYB W. L. GORE ASSOCIATES 9721614

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death GLUCOSE SODIUM| OMEPRAZOLE| TYLENOL| SODIUM CHLORIDE| BUPROPION| MAGNESIUM HYDROXIDE| LABETALOL| BENADRYL| MORPHINE| ASPIRIN| LOSARTAN