BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD G2 VENA CAVA FILTER SYSTEM

    MDR report key: 2042965 · Received March 28, 2011

    Report

    Report Number
    2042965
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 28, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 26 MONTHS AGO, PATIENT DEVELOPED DEEP VEIN THROMBOSIS OF THE LEFT LOWER EXTREMITY AND PULMONARY EMBOLI. AT THAT TIME A BARD G2 FILTER SYSTEM WAS PLACED IN THE INFRARENAL POSITION WITHOUT COMPLICATION. ABOUT FOUR MONTHS AGO CHEST X-RAY NOTED A THIN 3 CM IN LENGTH WIRE OPACITY WAS OVERLYING THE LEFT HEART BORDER. IT LIKELY REPRESENTED A SMALL WIRE FRAGMENT EMBOLIZED TO THE LUNG. A CT SCAN WAS PERFORMED SEVEN WEEKS AGO WHICH DEMONSTRATED A RETAINED WIRE FRAGMENT IN THE LEFT LOWER LOBE PULMONARY ARTERY. THE FINDING WAS DISCUSSED WITH THE PATIENT AND THAT THE SMALL FRAGMENT WAS OF NO CONSEQUENCE AND THERE WOULD NOT BE AN ATTEMPT TO RETRIEVE IT. FURTHER DISCUSSION WITH THE PATIENT REGARDING THE RISK OF FURTHER FRACTURES OF THE INDWELLING FILTER WAS DONE AND PATIENT VERBALIZED THE RISK AND AGREED TO REMOVAL. THE IVC FILTER WAS AGAINST THE WALL OF THE INFERIOR VENA CAVA. ONE WEEK AGO, AN INFERIOR VENACAVOGRAM WITH INFERIOR VENA CAVA FILTER REMOVAL WAS PERFORMED WITH SUCCESSFUL RETRIEVAL OF THE BARD G-2 FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD G2 VENA CAVA FILTER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BARD PERIPHERAL VASCULAR INC. * GFS12184

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR NO OTHER THERAPIES