BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 FILTER SYSTEM, JUGULAR

    MDR report key: 1032834 · Received April 22, 2008

    Report

    Report Number
    2020394-2008-00098
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 9, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K052578
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT THE LOT MET ALL RELEASE CRITERIA. THE SAMPLE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THE 4-X-RAY IMAGES WERE RETURNED FOR EVALUATION. THE FIRST IMAGE (6:49PM) SHOWED THE FILTER WITH THE APEX STRAIGHT IN THE VENA CAVA, WITH THE ARMS FULLY DEPLOYED AND THE LEGS VERY CLOSE TOGETHER. THE NEXT IMAGE (7:31:24PM) SHOWS THE FILTER IN AN APPROXIMATE 30 DEGREE TILTED POSITION, WITH THE LEGS UNCHANGED. THE FINAL 2 IMAGES WERE DUPLICATES, TAKEN AT 7:31:29PM AND WERE THE SAME AS THE PREVIOUS IMAGE. BASED ON THE QUALITY OF THE IMAGES RETURNED, THE REPORTED TILTING COULD BE CONFIRMED. HOWEVER, THE REPORTED APEX IN THE RENAL VEIN COULD NOT BE CONFIRMED. THE CAUSE OF THE TILTING IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENA CAVA FILTER WAS IMPLANTED, TILTED AND HAD ONE COMPONENT IN THE RENAL VEIN. THE DOCTOR ATTEMPTED TO REMOVE THE FILTER, BUT DUE TO THE TILT, HE WAS NOT ABLE TO. A SECOND FILTER WAS IMPLANTED SUPRARENAL, ABOVE THE FIRST FILTER THAT WAS TILTED. THIS WAS DONE PROPHYLACTICALLY DUE TO THROMBUS IN BOTH ILIAC VEINS, PRIOR TO A PROCEDURE WITH A TRELLIS THROMBECTOMY CATHETER, VIA A POPLITEAL ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM, JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. GFRL2048

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention