BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS

    MDR report key: 2854130 · Received November 27, 2012

    Report

    Report Number
    3002808486-2012-00033
    Event Type
    Injury
    Date Received
    November 27, 2012
    Date of Event
    October 28, 2012
    Report Date
    November 20, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    SIZING OF THE IVC DETERMINED FROM (B)(6) 2012 CT IMAGE (15.9MM-20.4MM). DUE TO THE PREVIOUS REACTION TO CONTRAST, THE FILTER WAS PLACED "BLIND" VIA L FEMORAL APPROACH WITH MINIMAL TILT BASED ON INTRAOPERATIVE X-RAY. DISTAL ASPECT OF FILTER PLACED AT L3-L4 WITH HOOK POSITIONED NEAR L2. SUCCESSFUL PLACEMENT OF FILTER, PATIENT LATER DISCHARGED. PATIENT RETURNED 1-2 WEEKS AFTER FILTER PLACEMENT COMPLAINING OF SHORTNESS OF BREATH AND CHEST PAIN. SINCE PATIENT HAD A FILTER IN PLACE, PATIENT WAS EVALUATED FOR MI. CHEST X-RAY SHOWED THE CELECT FILTER HAD MIGRATED TO RIGHT ATRIUM OF THE HEART (NEAR T10-T11) AND WAS SITUATED WITH 70-80 DEGREES OF TILT. ENDOVASCULAR RETRIEVAL OF THE FILTER WAS DISCUSSED BUT NOT CONSIDERED A VIABLE OPTION. THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL WHERE THE FILTER WAS REMOVED AND RETRIEVED SUCCESSFULLY AND THE PATIENT IS RECOVERING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Life Threatening| R