BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 FILTER SYSTEM

    MDR report key: 1903497 · Received November 16, 2010

    Report

    Report Number
    2020394-2010-00339
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS NOT KNOWN. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS DISCARDED BY THE USER FACILITY. THEREFORE, A SAMPLE EVAL COULD NOT BE PERFORMED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE DEFINITIVE ROOT CAUSE IS UNK. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS: FILTER FRACTURES ARE A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN SOME REPORTS OF SERIOUS PULMONARY AND CARDIAC COMPLICATIONS WITH VENA CAVA FILTERS REQUIRING THE RETRIEVAL OF THE FRAGMENT UTILIZING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. POTENTIAL COMPLICATIONS: COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: PAIN, FILTER FRACTURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE FILTER LIMBS DETACHED. REPORTEDLY, APPROXIMATELY TWO YEARS AFTER FILTER IMPLANT, THE PT PRESENTED WITH CARDIAC ARRHYTHMIAS, CHEST PAIN AND WAS SHORT OF BREATH (SOB). CT SCANS DEMONSTRATED THAT THE PT HAD PERICARDITIS AND HAD FLUID WITHIN THE PERICARDIUM. A PERICARDIAL DRAIN WAS PLACED AND THE PT WAS DISCHARGED. APPROXIMATELY FIVE MONTHS LATER, THE PT PRESENTED WITH RECURRENT CHEST PAIN AND SOB. A CARDIAC CT DEMONSTRATED TWO ARTIFACTS WITHIN THE HEART, ONE WITHIN THE RIGHT VENTRICLE, AND THE OTHER APPEARED TO BE THROUGH THE MYOCARDIUM AND INTO THE PERICARDIUM. ATTEMPTS TO RETRIEVE THE FILTER AND DETACHED COMPONENTS WERE NOT PERFORMED AT THAT TIME. THE PT RETURNED FIVE MONTHS LATER, AND THE FILTER WAS REMOVED WITH A RECOVERY CONE WITHOUT DIFFICULTY. DURING RETRIEVAL, IMAGING DEMONSTRATED ANOTHER FRACTURED LIMB, ENDOTHELIALIZED WITHIN THE IVC. ATTEMPTS TO RETRIEVE THE DETACHED COMPONENTS HAVE NOT PERFORMED TO DATE. THE PT IS REPORTED TO BE IN STABLE CONDITION.

    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 Life Threatening