BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 EXPRESS FILTER SYSTEM

    MDR report key: 6084125 · Received November 7, 2016

    Report

    Report Number
    2020394-2016-01038
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    August 13, 2015
    Report Date
    October 12, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K080668
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. VISUAL INSPECTION: THE DEVICE WAS NOT RETURNED; THEREFORE, A VISUAL INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: THE DEVICE WAS NOT RETURNED; THEREFORE, A FUNCTIONAL/PERFORMANCE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE DEVICE WAS NOT RETURNED. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FILTER TILT AND FILTER LIMB DETACHMENT. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS/POTENTIAL COMPLICATIONS: 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. MOVEMENT, MIGRATION OR TILT OF THE FILTER ARE KNOWN COMPLICATIONS OF VENA CAVA FILTERS. MIGRATION OF FILTERS TO THE HEART OR LUNGS HAS BEEN REPORTED. FILTER MALPOSITION. FILTER TILT. ALL OF THE ABOVE COMPLICATIONS HAVE BEEN ASSOCIATED WITH SERIOUS ADVERSE EVENTS SUCH AS MEDICAL INTERVENTION AND/OR DEATH. THERE HAVE BEEN REPORTS OF COMPLICATIONS, INCLUDING DEATH, ASSOCIATED WITH THE USE OF VENA CAVA FILTERS IN MORBIDLY OBESE PATIENTS. THE RISK/BENEFIT RATIO OF ANY OF THESE COMPLICATIONS SHOULD BE WEIGHED AGAINST THE INHERENT RISK/BENEFIT RATIO FOR A PATIENT WHO IS AT RISK OF PULMONARY EMBOLISM WITHOUT INTERVENTION. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY SIX YEARS POST FILTER DEPLOYMENT DURING A FILTER RETRIEVAL PROCEDURE, GUIDED FLUOROSCOPY DEMONSTRATED A TILTED FILTER WITH A DETACHED FILTER LIMB. THE FILTER AND DETACHED LIMB WERE RETRIEVED WITHOUT INCIDENT AND ANOTHER FILTER WAS DEPLOYED. THE PATIENT STATUS AT THIS TIME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734752 G2 EXPRESS FILTER SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1