BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 FILTER SYSTEM

    MDR report key: 1053364 · Received May 28, 2008

    Report

    Report Number
    2020394-2008-00148
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 8, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNKNOWN. THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION, SO A SAMPLE EVALUATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION RECEIVED, THE RESULTS ARE INCONCLUSIVE AND THE ROOT CAUSE OF THE EVENT IS UNKNOWN. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: POTENTIAL COMPLICATIONS: CAVAL THROMBOSIS/OCCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH SCROTAL AND LEG EDEMA. IT WAS DISCOVERED THAT THE VENA CAVA FILTER THAT WAS IMPLANTED 22 MONTHS EARLIER, PRIOR TO NEUROSURGERY, HAD A COMPLETE OCCLUSION OF THE IVC BELOW THE FILTER EXTENDING INTO BOTH ILIACS. THE PHYSICIAN FELT THAT THE FILTER WAS THE CAUSE OF CAVA THROMBOSIS, BUT DID NOT KNOW WHEN THE ONSET OF THE SYMPTOMS WERE. TPA INFUSIONS WERE DONE, WHICH OPENED THE VESSEL UP A LITTLE. THE VENA CAVA FILTER WAS REMOVED WITHOUT DIFFICULTY, AND THE PHYSICIAN THEN STENTED THE IVC AND BOTH ILIACS. ANOTHER VENA CAVA FILTER WAS THEN IMPLANTED PER THE FAMILIES REQUEST. PATIENT IS CURRENTLY DOING WELL.

    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 51 YR Required Intervention