BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRAPEASE FILTER

    MDR report key: 1864440 · Received October 12, 2010

    Report

    Report Number
    9610978-2010-00195
    Event Type
    Death
    Date Received
    October 12, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 15, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.NO ADDITIONAL PATIENT, LESION/VESSEL OR PROCEDURAL INFORMATION IS AVAILABLE. AT THIS TIME THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT.

    Description of Event or Problem · 1

    USOH ET AL REPORT IN THE AUGUST 2010 EDITION OF THE AMERICAN VENOUS FORUM ON A "PROSPECTIVE RANDOMIZED STUDY COMPARING THE CLINICAL OUTCOMES BETWEEN INFERIOR VENA CAVA GREENFIELD AND TRAPEASE FILTERS" THAT A PATIENT TREATED WITH A TRAPEASE FILTER DIED WITHIN 30 DAYS DUE TO UNKNOWN CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEASE FILTER THROMBECTOMY SYSTEMS (DQO) DTK CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death