BEUDAMED
    FDA Adverse Event Death Summary report: N

    GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER

    MDR report key: 1594555 · Received February 2, 2010

    Report

    Report Number
    1820334-2010-00039
    Event Type
    Death
    Date Received
    February 2, 2010
    Date of Event
    July 3, 2009
    Report Date
    January 5, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    PMA / PMN Number
    P850049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS UNK AS NOT PROVIDED BY REPORTER. (B) (4). MFR DATE: UNK AS LOT IS UNK. EACH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) THAT LISTS THE ANATOMICAL REQUIREMENTS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. INSPECTIONS ARE PERFORMED ON ALL CANNULAS ON FILTER ARE SOLDERED SECURELY AND SOLDER IS SMOOTH AND FREE OF EXCESSIVE SHARPNESS AND VERIFIES THAT FILTER IS LOADED PROPERLY INTO THE DELIVERY SYSTEM. WITHOUT THE RETURNED PRODUCT OR IMAGES, IT IS DIFFICULT TO DETERMINE WHAT MAY HAVE LED TO THIS FAILURE. IT IS POSSIBLE THAT THE DEVICE WAS DAMAGED BECAUSE OF TRAUMA THE PT EXPERIENCED, INCORRECT PLACEMENT, OR UNFORESEEN PT'S ANATOMICAL/PHYSIOLOGICAL FACTORS. REGARDLESS, WE WILL NOTIFY THE APPROPRIATE PERSONNEL OF THE EVENT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IVC FILTER PLACEMENT IN 2009. IT WAS FIRST DISCOVERED TO HAVE MIGRATED THREE MONTHS LATER, BASED ON CT ANGIOGRAM AND CHEST X-RAY. SUBSEQUENTLY, THE PT DEVELOPED TAMPONADE. THE PT EXPIRED, AND AT THE AUTOPSY THERE WAS A MICROPERFORATION OF A STRUT FROM THE SEPARATED FILTER. THE STRUT WAS LOCATED AT THE RIGHT ATRUM AND SUPERIOR VENA CAVA. THERE WAS A 250 CC BLOOD CLOT AND FIBRIN AT THE PERICARDIAL SAC AND 525 CC OF BLOOD IN THE RIGHT PLEURAL CAVITY. THE PT EXPIRED. THE DATE OF PT'S DEATH IS UNK AS NOT PROVIDED BY REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death