BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM

    MDR report key: 919542 · Received September 21, 2007

    Report

    Report Number
    2020394-2007-00261
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    August 9, 2007
    Report Date
    August 22, 2007
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR COULD NOT BE REVIEWED AS THE LOT NUMBER IS NOT KNOWN. THE CATALOG NUMBER IS NOT KNOWN; HOWEVER, THE 501K NUMBER FOR G2 FEMORAL IS K062887 AND G2 JUGULAR IS K052578. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, THE RESULTS ARE INCONCLUSIVE AND THE ROOT CAUSE OF THE EVENT IS UNKNOWN. THE CURRENT IFU (INSTRUCTIONS FOR USE) FOR THIS DEVICE STATES: COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POTENTIAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: MIGRATION. MOVEMENT OR MIGRATION OF THE FILTER IS A KNOWN COMPLICATION OF VENA CAVA FILTERS. THIS MAY BE CAUSED BY PLACEMENT IN IVCS WITH DIAMETERS EXCEEDING THE APPROPRIATE LABEL DIMENSIONS SPECIFIED IN THE IFU. THE CURRENT IFU (INSTRUCTIONS FOR USE) ON POTENTIAL COMPLICATIONS STATES: FILTER FRACTURE IS A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN REPORTS OF EMBOLIZATION OF VENA CAVA FILTER FRAGMENTS RESULTING IN RETRIEVAL OF THE FRAGMENT USING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. MOST CASES OF THE FILTER FRACTURE, HOWEVER, HAVE BEEN REPORTED WITHOUT ANY ADVERSE CLINICAL SEQUELAE. THE REMOVAL OF THIS FILTER IS CONSIDERED TO BE AN OFF LABEL USE OF THIS DEVICE. THE CURRENT IFU (INSTRUCTIONS FOR USE) FOR THIS DEVICE STATES: THE G2 FILTER IS DESIGNED TO ACT AS PERMANENT FILTER. THE SAFETY AND EFFECTIVENESS OF THE G2 FILTER SYSTEM AS A RETRIEVABLE OR TEMPORARY FILTER HAVE NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS DISCOVERED AT A SCHEDULED PROCEDURE TO REMOVE A VENA CAVA FILTER, THAT IT HAD MIGRATED CAUDALLY, WAS TILTED, AND HAD A FRACTURED LEG. THE FILTER WAS IMPLANTED POST TRAUMA FOUR MONTHS EARLIER. IT IS UNKNOWN IF THERE WERE ANY INTERVENTIONS AFTER THE FILTER WAS PLACED, AS THIS WAS IMPLANTED AT A DIFFERENT HOSPITAL. THE FILTER WAS REMOVED, BUT THE FRACTURED LEG REMAINS IN THE VENA CAVA. THE PATIENT IS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR