BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 X FILTER SYSTEM - FEMORAL

    MDR report key: 1941193 · Received December 9, 2010

    Report

    Report Number
    2020394-2010-00359
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K082305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE FILTER REMAINS IMPLANTED. THEREFORE, A SAMPLE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FILTER MIGRATED CAUDALLY AND FOUR FILTER LIMBS PERFORATED THE CAVA WALL. REPORTEDLY, SIX WEEKS AFTER FILTER IMPLANT, THE PT PRESENTED WITH ABDOMINAL PAIN. IMAGING DEMONSTRATED THAT THE FILTER MIGRATED CAUDALLY BY 4CM, ONE FILTER LIMB PERFORATED THE VENA CAVA INTO THE MESENTERIC FAT AND THREE FILTER LIMBS EXTENDED INTO THE PRE-VERTEBRAL SOFT TISSUE. THE FILTER WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 X FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFTF3724

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR