BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM GREENFIELD VENA CAVA FILTER

    MDR report key: 1031449 · Received April 18, 2008

    Report

    Report Number
    2134265-2008-01132
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Report Date
    March 21, 2008
    Product Code
    DTK
    PMA / PMN Number
    K912035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE FILTER FAILED TO EXPAND. THE 12FR JUGULAR TITANIUM GREENFIELD WAS ADVANCED TO THE INTERIOR VENA CAVA AND DEPLOYED, HOWEVER, THE FILTER FAILED TO "EXPAND ALL THE WAY". IT HAS NOT KNOWN IF THE FILTER WAS REMOVED FROM THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S STATUS IS UNKNOWN. ADDITIONAL INFO HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM GREENFIELD VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK NA 11422631

    Patients

    Seq Age Sex Outcome Treatment
    1