BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM, FEMORAL

    MDR report key: 1062244 · Received June 17, 2008

    Report

    Report Number
    2020394-2008-00167
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNK. THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION, AS IT REMAINS IMPLANTED. X-RAYS (VENACAVAGRAMS) OF THE INITIAL IMPLANT AND OF THE ATTEMPTED RETRIEVAL WERE REVIEWED. THE TILTING OF THE FILTER WAS CONFIRMED, AS WELL AS A CAUDAL MIGRATION. HOWEVER, BASED ON THE FILMS RETURNED, THE DISTANCE OF 3.8CM REPORTED FOR THE MIGRATION COULD NOT BE CONFIRMED. THE ROOT CAUSE FOR THIS EVENT IS UNK. THE CURRENT IFU (INSTRUCTION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED RETRIEVAL, A VENA CAVA FILTER WAS FOUND TO BE TILTED AND HAD CAUDALLY MIGRATED 3.8 CMS. THE FILTER WAS PLACED IN A FEMALE 5 WEEKS EARLIER, FOR DVT'S. THIS IS NOT THE FIRST TIME SHE HAD A FILTER PLACED FOR DVT. THE PHYSICIAN USED A CONE RETRIEVAL SYSTEM, BUT WAS UNABLE TO REMOVE IT DUE TO THE MIGRATION AND 30 DEGREE TILT. ONE OF THE UPPER LIMBS REMAINED IN THE ORIGINAL POSITION, WHICH CAUSED THE REST OF THE FILTER TO TILT. THE APEX WAS ANTERIOR TO THE CAVA WALL. THE SIZE OF THE VENA CAVA IS 21MM. THE ORIGINAL PLACEMENT SITE WAS INFRARENAL USING A JUGULAR APPROACH. THE PHYSICIAN DOES PLAN TO MAKE ANOTHER ATTEMPT AT RETRIEVAL IN THE FUTURE, BUT IT HAS NOT YET BEEN SCHEDULED. NO PT INJURY REPORTED AND THE PT REMAINS ASYMPTOMATIC AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR