BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 FILTER SYSTEM - UNK

    MDR report key: 1040163 · Received May 9, 2008

    Report

    Report Number
    2020394-2008-00126
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RETURNED; HOWEVER, EVAL HAS NOT BEEN COMPLETED. BASED ON THE INFO AVAILABLE TO DATE, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNKNOWN. THE CURRENT INFO FOR USE (IFU) FOR THIS DEVICE STATES: POTENTIAL COMPLICATIONS: FILTER FRACTURE IS A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN REPORTS OF EMBOLIZATION OF VENA CAVA FILTER FRAGMENTS RESULTING IN RETRIEVAL OF THE FRAGMENT USING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. MOST CASES OF FILTER FRACTURE, HOWEVER, HAVE BEEN REPORTED WITHOUT ANY ADVERSE CLINICAL SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENA CAVA FILTER WAS REMOVED SUCCESSFULLY, HOWEVER, TWO COMPONENTS WERE DETACHED. IT IS NOT KNOWN IF THIS WAS AN INCIDENTAL FIND OR IF THE PT WAS SYMPTOMATIC. ONE COMPONENT WAS RETRIEVED, BUT THE OTHER ONE REMAINS IN THE PT AND HAS EMBOLIZED TO THE LUNG. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE PHYSICIAN AND CONTACT. NO REPORTED INJURY TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention