BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 2470666 · Received February 24, 2012

    Report

    Report Number
    3002808486-2012-00007
    Event Type
    Death
    Date Received
    February 24, 2012
    Report Date
    January 30, 2012
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE HAVE CONDUCTED AN INVESTIGATION BASED ON THE AVAILABLE INFO. SINCE NO PRODUCT OR IMAGES ARE AVAILABLE, THE INVESTIGATION IS BASED ONLY ON THE VERY LIMITED INFO PROVIDED. IMPLANT PERIOD IS UNK AND ALSO IT IS UNK IF THE PT HAD ANY KIND OF TREATMENT, WHICH COULD HAVE EXPOSED THE FILTER TO MANIPULATION DURING THE IMPLANT PERIOD. THEREFORE, DIFFICULT TO COMMENT ON THE FEET OF THE FILTER APPEAR TO HAVE PENETRATED THE VESSEL WALLS. FILTER PERFORATION OF THE VENA CAVA WALL IS A WELL KNOWN RISK. BASED ON THE LIMITED INFO, WE ARE UNABLE TO CONCLUDE THE EXACT ROOT CAUSE TO THIS EVENT. HOWEVER, IT IS VERY UNLIKELY THAT A FILTER PERFORATION SHOULD LEAD TO SUCH SERIOUS COMPLICATIONS. NOTHING FURTHER IS INITIATED SINCE THE DESCRIPTION DOES NOT INDICATE PRESENCE OF DEVICE FAILURE. WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    PT CAME IN WITH SYMPTOMS OF VENA CAVA THROMBOSIS. ON VISUALIZATION, COMPLETE IVC THROMBOSIS WAS NOTED. THE FEET OF THE FILTER APPEAR TO HAVE PENETRATED THE VESSEL WALLS. THE PT CODED ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death