BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORDIS

    MDR report key: 1071468 · Received July 10, 2008

    Report

    Report Number
    1071468
    Event Type
    Death
    Date Received
    July 10, 2008
    Date of Event
    May 1, 2008
    Report Date
    July 3, 2008
    Manufacturer
    CORDIS
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNDERWENT MICRODISCECTOMY AND PLIF IN '08 WITHOUT COMPLICATIONS. IN THE NEXT DAY, C/O SHORTNESS OF BREATH AND CONFUSION AND A CHEST CT REVEALED A PE. AN MRI OF THE BRAIN WAS INDICATIVE OF A LEFT INSULAR CORTICAL STROKE. ATTEMPTS TO PERFORM A TPA EMBOLECTOMY WERE UNSUCCESSFUL DUE TO A TORTUOSUS LEFT CAROTID ARTERY AND AN OPTEAS BIRDS NEST FILTER WAS PLACED IN THE INFERIOR VENA CAVA BELOW THE LEVEL OF THE RENAL VEIN. A TEE PERFORMED IN THE NEXT DAY DID DEMONSTRATED A PATENT FORAMEN OVALE AND HE WAS FELT TO HAVE A NEUROLOGIC EMBOLISM. ABOUT 3 DAYS LATER, COUMADIN THERAPY WAS STARTED. IN THE NEXT DAY, WHILE SITTING IN CHAIR BECAME ANEMIC AND RESUSCITATION EFFORTS WERE UNSUCCESSFUL. AUTOPSY REVEALED FILTER PRESENT IN RIGHT VENTRICULAR LUMEN. (SEE SCANNED PAGE)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS OPTEAS RETRIVABLE BIRD'S NEST FILTER DTK CORDIS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death