BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEASE IVC FILTER

    MDR report key: 422521 · Received October 15, 2002

    Report

    Report Number
    MW1026444
    Event Type
    Malfunction
    Date Received
    October 15, 2002
    Report Date
    October 15, 2002
    Manufacturer
    CORDIS, OF JOHNSON AND JOHNSON
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WITH METASTATIC BREAST CANCER HAD PLACEMENT OF IVC TRAPEASE FILTER AT HOSP FOR PULMONARY EMBOLISM 2 WEEKS AGO NOW WITH INCREASED SEVERE BILATERAL LEG SWELLING FOR 3 DAYS. THROMBOSIS OF IVC, ILIACS AND BILATERAL CFV, SFV AND POPLITEAL VEINS FOUND ON DUPLEX. CAVOGRAPHY CONFIRMS THROMBOSIS OF IVC TRAPEASE FILTER. PT WAS ALSO ON COUMADIN POST FILTER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEASE IVC FILTER FILTER DTK CORDIS, OF JOHNSON AND JOHNSON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other