BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 FILTER SYSTEM

    MDR report key: 1033709 · Received April 25, 2008

    Report

    Report Number
    2020394-2008-00106
    Event Type
    Injury
    Date Received
    April 25, 2008
    Report Date
    April 2, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULT OF THE INVESTIGATION WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVAL. THE CURRENT IFU (INSTRUCTION FOR USE) FOR THIS DEVICE STATES: COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POTENTIAL COMPLICATIONS INCLUDED, 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 (INSTRUCTION FOR USE) STATES: POTENTIAL COMPLICATIONS. POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING: CAVAL THROMBOSIS/OCCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS BROUGHT BACK INTO THE HOSP DUE TO SYMPTOMS OF SWELLING AND PAIN. THE PT HAD RECEIVED A VENA CAVA FILTER WITHIN THE PAST WEEK (INDICATION UNK). THE DOCTOR NOTICED ON AN IMAGE THAT THERE WAS A CAUDAL MIGRATION. HE FELT THAT IT HAD CAUSED A SIGNIFICANT VASCULAR EVENT, PHLEGMASIA. THE VENA CAVA WAS COMPLETELY THROMBOSED AND THE DOCTOR FEARS THAT THE PT MAY LOSE HIS LEG. THE FILTER SHIFTED DOWN SEVERAL CMS FROM THE INFRARENAL PLACEMENT. NO ADD'L INFO IS AVAILABLE.

    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 Required Intervention