BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD ECLIPSE VENA CAVA FILTER

    MDR report key: 2192656 · Received August 1, 2011

    Report

    Report Number
    MW5021591
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, BARD INFERIOR VENA CAVA FILTER WAS PLACED PRIOR TO (B)(6) 2011 BARIATRIC SURGERY. ON (B)(6) 2011, INFERIOR VENA CAVOGRAM AND FLUOROSCOPY PERFORMED WHICH REVEALED SINCE THE INITIAL PLACEMENT, THE FILTER HAD MIGRATED CAUDALLY AND ONE LEG OF THE FILTER EXTENDED BEYOND THE MEDIAL WALL OF THE CAVA. A SNARE WAS UTILIZED TO ENGAGE THE HOOK ON THE TOP OF THE FILTER. THE INFERIOR VENA CAVA FILTER WAS SUCCESSFULLY REMOVED. PT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD ECLIPSE VENA CAVA FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFUK1001

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR