BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM, JUGULAR

    MDR report key: 1171958 · Received September 19, 2008

    Report

    Report Number
    2020394-2008-00261
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 22, 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 WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS LOT MET ALL RELEASE CRITERIA. THE SAMPLE HAS NOT BEEN RETURNED AS IT WILL NOT BE RELEASED BY THE HOSPITAL. WITH THE INFORMATION RECEIVED AND THE EVALUATION, THE RESULT OF THE INVESTIGATION WAS INCONCLUSIVE AND THE ROOT CAUSE OF THE EVENT IS UNKNOWN. THE CURRENT INFORMATION FOR USE (IFU) STATES: 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 ALLEGEDLY TWO LIMBS FROM A G2 FILTER DETACHED AND MIGRATED. THE FILTER WAS IMPLANTED ONE AND ONE HALF YEARS PRIOR, DUE TO DVT IN THE PRESENCE OF TRAUMA (BROKEN WRIST). THE PATIENT RECENTLY PRESENTED WITH CHEST PAIN. THE PHYSICIAN ORDERED A CARDIAC CATH PROCEDURE AND ALLEGEDLY DISCOVERED A LIMB IN THE PULMONARY ARTERY, WHICH WAS REMOVED BY SNARING IT. THE OTHER REMAINS ADHERED TO THE ATRIAL WALL. THE FILTER WAS REMOVED WITH A CONE RETRIEVAL SYSTEM, WITHOUT INCIDENT. THE PATIENT IS NOW ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM, JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. GFRD3469

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention