BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI VENA CAVA FILTER

    MDR report key: 5546952 · Received March 31, 2016

    Report

    Report Number
    MW5061473
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    May 30, 2015
    Report Date
    March 31, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD IVC FILTER IMPLANTED FOR TREATMENT OF DVT IN RIGHT LEG. TWO DAYS LATER I HAD A SEVER SIDE EFFECT. THERE WAS A MAJOR INCREASE IN THE SEVERITY OF THE DVT INCLUDING MULTIPLE PE. THE NEW CLOTS STARTED AT THE IVC FILTER AND SPREAD DOWN BOTH LEGS. I SPENT 14 DAYS IN INTENSIVE CARE WITH 14 HOURS INTERVENTIONAL RADIOLOGIC PROCEDURES TO RESTORE BLOOD FLOW TO MY LEGS. AFTER NEARLY A YEAR OF COMPRESSION SOCKS WORN 24/7 AND BLOOD THINNERS I STILL HAVE SEVER SWELLING OF MY CALF'S AND ONGOING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195846 DENALI VENA CAVA FILTER INTRAVASCULAR FILTER DTK BARD PERIPHERAL VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R| S