BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT FEMORAL VENA CAVA FILTER SET

    MDR report key: 1945577 · Received November 30, 2010

    Report

    Report Number
    3002808486-2010-00017
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 12, 2010
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE DESCRIPTION ONLY, THIS COMPLAINT WAS EVALUATED ON A MEETING 17-NOV-2010 WITH PARTICIPATION OF MEDICAL ADVISOR AND DIRECTOR OF RESEARCH. IT HAS NOT BEEN POSSIBLE TO OBTAIN ANY ADDITIONAL INFORMATION, SO IT IS NOT CLEAR WHY THE FILTER SHOULD BE RETRIEVED. DID THE FILTER PERFORATE VENA CAVA WALL OR NOT? ALSO IT IS NOT CLARIFIED IF THE FILTER LEG ACTUALLY DID FRACTURE DURING THE SECOND ATTEMPT OF RETRIEVAL OR IF THE FRACTURE WAS ONLY OBSERVED AT THAT TIME. IT IS POSSIBLE THAT MANIPULATION DURING FIRST ATTEMPT OF RETRIEVAL CAUSED CHANGES TO THE FILTER CONFIGURATION AND STRESS TO THE WIRE (LEG). ACCORDING TO THE DESCRIPTION, A SCAN SHOWED AN IVC THROMBUS, CAUSED BY THE FILTER LEG ERODED INTO L3 VERTEBRA. MOST LIKELY IT IS NOT AN IVC THROMBUS BUT A HEMATOMA CAUSED BY THE FRACTURED LEG. SINCE NO ADDITIONAL INFORMATION OR IMAGES HAS BEEN AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE TO THIS INCIDENT.

    Description of Event or Problem · 1

    AN UNSUCCESSFUL ATTEMPT WAS MADE TO RETRIEVE AN IVC FILTER. APPROX A MONTH LATER, A SECOND ATTEMPT WAS MADE WHICH WAS SUCCESSFUL EXCEPT THAT ONE OF THE STRUTS FRACTURED AND WAS RETAINED. TWO DAYS LATER, THE ULTRASOUND AND CT SCANS REVEALED THAT THE FRACTURED FILTER STRUT WAS EMBEDDED INTO THE L3 VERTEBRAL BODY. ALSO THE SCANS REVEALED AN IVC THROMBUS THAT WAS NOT EVIDENT ON THE DAY OF THE RETRIEVAL, THAT MAY HAVE BEEN CAUSED BY THE FRACTURED STRUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE NA E2480416

    Patients

    Seq Age Sex Outcome Treatment
    1 Other