BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER

    MDR report key: 2221247 · Received August 17, 2011

    Report

    Report Number
    3002808486-2011-00029
    Event Type
    Injury
    Date Received
    August 17, 2011
    Report Date
    July 15, 2011
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FROM AUGUST 08, 2011, IS ONLY BASED ON THE DESCRIPTION ONLY, SINCE IMAGES AND PRODUCT HAVE NOT BEEN AVAILABLE. (B)(4). THE EVAL OF THIS COMPLAINT WAS BASED ON THE DESCRIPTION ONLY SINCE NO IMAGES HAVE BEEN AVAILABLE. WITHOUT CT SCANS, IT IS NOT POSSIBLE TO DETERMINE IF THE FILTER PERFORATES THE IVC OR IF THE FILTER IS JUST IN A TENTING SITUATION. BASED ON A REVIEW OF THE CLINICAL LITERATURE, COOK HAS CONCLUDED THAT VENA CAVA FILTERS DISTORT THE VESSEL LUMEN SO THAT THE ANCHORING POINTS OF THE FILTER APPEARS OUTSIDE THE BLOOD FLOW FLUOROSCOPICALLY VISUALIZED. MOREOVER, THIS DISTORTION OR "TENTING" IS NOT UNIQUE TO THE CELECT FILTER. TENTING IS A GENERIC PROPERTY OF THIS CLASS OF DEVICE. HOWEVER, FILTER PERFORATION OF THE VENA CAVA WALL IS A WELL KNOWN RISK. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE FILTER PERFORATION OF THE VENA CAVA WALL. DESPITE PERFORATION, THEY ALL END UP IN SUCCESSFUL FILTER RETRIEVAL. NO OTHER COMPLAINTS RECEIVED ON THIS LOT NUMBER.

    Description of Event or Problem · 1

    THE PT HAD A COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER PLACED IN (B)(6) 2010. DURING A FOLLOW-UP VISIT IN (B)(6) 2011, AN ABDOMEN PELVIS CT SCAN DEMONSTRATED THE FILTER IS NOTED IN THE IVC AND FOUR OF THE WIRES HAVE PASSED OUTSIDE THE IVC AS PRESENT ON THE PRIOR STUDY WITH A PRONG THROUGH THE AORTA, DUODENUM AND INTO THE L4 VERTEBRAL BODY. THE PT HAS NO DISCOMFORT, AND IS STABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE NA E2281675

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening