BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT FEMORAL VENA CAVA FILTER

    MDR report key: 1833022 · Received July 19, 2010

    Report

    Report Number
    3002808486-2010-00007
    Event Type
    Injury
    Date Received
    July 19, 2010
    Date of Event
    April 26, 2009
    Report Date
    June 29, 2010
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RETURNED, BUT EVALUATION IS BASED ON THE RETURNED IMAGES, ONLY LIMITED CT SCANS AVAILABLE. IMAGES FROM THE (B)(6) 2010 SHOW FILTERLEGS PERFORATING THE VENA CAVA WALL AND EXTENDING INTO THE DUODENUM. THIS IS CONFIRMED BY THE IMAGES FROM THE ENDOSCOPY PROCEDURE, BUT IT DOES NOT CLEARLY APPEAR WHICH ARE PRIMARY LEGS AND WHICH ARE SECONDARY LEGS. ANOTHER FILTER LEG IS NEAR THE VERTEBRA (LUMBAR DISC). THE FILTER IS NOT SIGNIFICANTLY TILTED. THE EVALUATION IS BASED ON THE DESCRIPTION AND THE RETURNED IMAGES. AVAILABLE IMAGES FROM THE (B)(6) 2010 SHOW FILTERLEGS PERFORATING THE VENA CAVA WALL AND EXTENDING INTO THE DUODENUM. THIS IS CONFIRMED BY THE IMAGES FROM THE ENDOSCOPY PROCEDURE. ANOTHER FILTER LEG IS NEAR THE VERTEBRA. IT SHOULD BE NOTED THAT PROCEDURALLY MANIPULATION, IN THE AREA OF A DEPLOYED FILTER MAY CAUSE THE FILTER TO PERFORATE THE CAVAL WALL. 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. "THERE ARE NO PUBLISHED GUIDELINES FOR SURGICAL OR ENDOVASCULAR REMOVAL OF PERFORATED IVC FILTERS. REMOVAL IS CONSIDERED BASED ON THE SEVERITY OF SYMPTOMS AND PERCEIVED LONG TERM ADVERSE OUTCOMES", AS STATED IN ARTICLE [1]. THIS ARTICLE AND THE FOLLOWING THREE ARTICLES SEEM RELEVANT.

    Description of Event or Problem · 1

    IT WAS DISCOVERED DURING THIS PATIENT'S ENDOSCOPY PROCEDURE THAT STRUTS FROM THE PATIENT'S IVC FILTER EXTENDED INTO THE PATIENT'S DUODENUM. A CT STUDY WAS PERFORMED AND DR (B)(6) WAS CONSULTED TO POSSIBLY RETRIEVE THE CELECT IVC FILTER, BUT SEEING THAT THE STRUTS PENETRATED THE IVC INTO THE DUODENUM AND ALSO POSSIBLY A LUMBAR DISC, RECOMMENDED THE PATIENT HAVE THIS FILTER SURGICALLY REMOVED. THERE WERE NOT ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT FEMORAL VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E2323638

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other