BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERIDIAN FILTER SYSTEM - JUGULAR

    MDR report key: 2781978 · Received October 3, 2012

    Report

    Report Number
    2020394-2012-00224
    Event Type
    Death
    Date Received
    October 3, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K102511
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR CORPORATE LOT NUMBER GFWD3725. THE DEVICE WAS NOT RETURNED. IMAGES WERE PROVIDED. BASED ON THE IMAGES PROVIDED, THE COMPLAINT INVESTIGATION IS INCONCLUSIVE FOR FILTER CEPHALAD MIGRATION. IT SHOULD BE NOTED THAT THE FOLLOWING WAS REPORTED FOR THIS EVENT: THE FILTER WAS PLACED IN THE PT ON (B)(6). ON (B)(6) A CHEST X-RAY CONFIRMED GOOD FILTER PLACEMENT WITHIN THE IVC. PT EXPIRED ONE DAY LATER. IT WAS REPORTED BY A BARD REP THAT THE ALLEGED AUTOPSY REPORT INDICATED THAT THE DEATH WAS NOT ATTRIBUTED TO THE FILTER. THE PT EXPIRED DUE TO RESPIRATORY FAILURE AND CPR HAD NOT BEEN PERFORMED. ACCORDING TO THE BPV REP, THE PHYSICIAN BELIEVED THAT THE NATURAL OCCURRENCES DURING RESPIRATORY FAILURE MAY HAVE CONTRIBUTED TO THE FILTER MOVEMENT TO THE HEART. THE PATHOLOGIST AND PHYSICIAN AGREE THAT THE CEPHALAD MIGRATION OF THE FILTER COULD HAVE OCCURRED DUE TO A HEMODYNAMIC EVENT PRIOR TO THE PT'S DEATH. THE HEMODYNAMIC EVENT (DILATATION/RELAXATION OF THE VENA CAVA) LIKELY CAUSED THE FILTER FEET TO DISLODGE FROM THE VENA CAVA WALL, CAUSING THE FILTER TO TRAVEL CEPHALAD TO THE HEART. THREE RADIOGRAPHIC IMAGES WERE REVIEWED. A VENA CAVAGRAM TAKEN IMMEDIATELY AFTER IVC FILTER PLACEMENT DEMONSTRATES THE FILTER IN AN INFRARENAL POSITION. A RETRIEVAL HOOK IS VISIBLE AT THE APEX AND THE FILTER IS VERTICALLY ORIENTED IN THE IVC. NOT ALL OF THE FILTER LIMBS ARE VISIBLE IN THE IMAGE DUE TO THE SUBTRACTION MODALITY; HOWEVER, THE FILTER LIMBS APPEAR TO BE EXPANDED TO THE CAVAL WALL. A CHEST X-RAY TAKEN 24 HOURS AFTER FILTER PLACEMENT DOES NOT DEMONSTRATE THE FILTER COMPONENTS IN THE HEART OR LUNGS. TWO DIGITAL MEASUREMENTS OF THE IVC, 12MM X 28MM, ARE DISPLAYED IN ONE AXIAL CT IMAGE; HOWEVER, THERE ARE NO OTHER IMAGES PROVIDED FROM THE CT STUDY AND IT CANNOT BE DETERMINED EXACTLY WHERE IN THE IVC THE MEASUREMENTS WERE TAKEN. THE FILTER IS NOT VISIBLE IN THE CT IMAGE. NO IMAGES WERE PROVIDED OF THE FILTER IN THE HEART. BASED ON THE IMAGES PROVIDED, FILTER MIGRATION CANNOT BE CONFIRMED. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS AND POTENTIAL COMPLICATIONS: 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. THERE HAVE ALSO BEEN REPORTS OF CAUDAL MIGRATION OF THE FILTER. MIGRATION MAY BE CAUSED BY PLACEMENT IN IVCS WITH DIAMETER EXCEEDING THE APPROPRIATE LABELED DIMENSIONS SPECIFIED IN THIS IFU. MIGRATION MAY ALSO BE CAUSED BY IMPROPER DEPLOYMENT, DEPLOYMENT INTO CLOTS AND/OR DISLODGEMENT DUE TO LARGE CLOT BURDENS. ALL OF THE ABOVE COMPLICATIONS MAY BE 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 PTS. THE RISK/BENEFIT RATIO OF ANY OF THESE COMPLICATIONS SHOULD BE WEIGHED AGAINST THE INHERENT RISK/BENEFIT RATIO FOR A PT WHO IS AT RISK OF PULMONARY EMBOLISM WITHOUT INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAY AFTER SUCCESSFUL IVC FILTER IMPLANTATION IN A PT WITH END-STAGE AIDS, THE PT EXPIRED OF RESPIRATORY FAILURE. X-RAY IMAGES TAKEN AT THE TIME OF FILTER PLACEMENT AND THE NEXT DAY CONFIRMED GOOD PLACEMENT OF THE FILTER IN THE IVC. THE ALLEGED AUTOPSY REPORT INDICATED THE FILTER WAS FOUND IN THE RIGHT ATRIUM; HOWEVER, THE DEATH WAS NOT ATTRIBUTED TO THE FILTER. THE PHYSICIAN AND THE PATHOLOGIST BELIEVED THAT THE NATURAL OCCURRENCES DURING RESPIRATORY FAILURE OR A HEMODYNAMIC EVENT PRIOR TO THE PT'S DEATH COULD HAVE LED TO THE FILTER MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIDIAN FILTER SYSTEM - JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. GFWD3725

    Patients

    Seq Age Sex Outcome Treatment
    1 Death