BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD ECLIPSE FEMORAL VENA CAVA FILTER

    MDR report key: 2020654 · Received March 7, 2011

    Report

    Report Number
    2020654
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 9, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BARD
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    MVA PATIENT WITH TRAUMATIC BRAIN INJURY WAS TAKEN TO THE OR FOR INSERTION OF INFERIOR VENA CAVA (IVC) FILTER INSERTION. DURING A KIDNEY/URETERS/BLADDER (KUB) X-RAY IT WAS NOTED THAT THERE WAS A MARKED CHANGED IN APPEARANCE IN LOCATION OF OF THE IVC FILTER. IT APPEARED THAT THE IVC FILTER HAD MIGRATED. ON THE PRIOR EXAMINATIONS IT WAS ORIENTED ALONG THE SAME LONG AXIS AS THE SPINE AND HAD ITS CONE/RETRIEVAL HOOK AT THE MID PEDICLE LEVEL OF L1. IT WAS NOW DISPLACED INFERIORLY WITH THE CONE AT THE LEVEL OF L2 AND WAS SEVERELY TILTED TO THE RIGHT. ATTEMPT WAS MADE TO REMOVE THE FILTER WITHOUT SUCCESS. DECISION WAS MADE TO CONTINUE WITH NON OPERATIVE MANAGEMENT AND SURVEILLANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ECLIPSE FEMORAL VENA CAVA FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BARD * GFUG3534

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR