BEUDAMED
    FDA Adverse Event Summary report: N

    CRUX VENA CAVA FILTER SYSTEM

    MDR report key: 3760729 · Received April 4, 2014

    Report

    Report Number
    2939520-2014-00025
    Date Received
    April 4, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    K122585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS NOT RETURNED TO THE MFR AND THE SERIAL NUMBER OR LOT NUMBER OF THE FILTER SYSTEM WAS NOT REPORTED. THEREFORE, MFG DOCUMENTATION FOR THIS DEVICE WAS UNABLE TO BE REVIEWED TO CONFIRM THAT THE DEVICE MET ALL QUALITY AND MFG CRITERIA. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFG'S CLINICAL AFFAIRS DEPARTMENT COMPLETES THE EVAL REPORT OF THIS CASE.

    Description of Event or Problem · 1

    A (B)(6) FEMALE HAD CRUX VCF IMPLANTED SOMETIME IN (B)(6) 2013 PRIOR TO SCHEDULED PANCREATIC SURGERY. PT HAS A HISTORY OF VTE WITH CHRONIC DVT. THIS PT PRESENTED WITH LEG PAIN AND SWELLING. THE DOCTOR REPORTED, A CT SCAN WAS DONE WHICH SHOWED THROMBOSIS OF THE ILIAC VEINS AND IVC TO THE LEVEL OF THE CRUX VCF. THE PT WAS PUT ON ANTICOAGULANTS AND DEVELOPED A G1 BLEED SO IS NOW CONTRAINDICATED FOR ANTICOAGULANT TREATMENT. CT REPORT COMPLETED ON (B)(6) 2014 RECEIVED BY VOLCANO CORPORATION CUSTOMER SERVICE REP HAD NO MENTION OF ILIAC VEIN THROMBOSIS. THE PT HAD OPEN PANCREATIC SURGERY FOR CANCER AND HAD BEEN ON CHEMOTHERAPY. CURRENTLY, THE PT WAS DIAGNOSED WITH METASTATIC DISEASE. IT WAS REPORTED THAT THE PT HAD CHRONIC DVT LOWER THAN THE ILIAC VEINS AS WELL AS HYPER-COAGULAPHY. THE PT IS FEELING BETTER BUT REMAINS VERY SICK RELATED TO HER COMORBIDITIES. CURRENTLY, THERE WAS NO PLANS FOR INTERVENTION OF THE CRUX VCF THROMBOSIS AND AT THIS TIME, NO SURGICAL INTERVENTION IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203594 CRUX VENA CAVA FILTER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK VOLCANO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR