BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN FILTER SYSTEM- FEMORAL

    MDR report key: 3221548 · Received July 1, 2013

    Report

    Report Number
    2020394-2013-00193
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K112497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MFG REVIEW COULD NOT BE CONDUCTED AS THE INVESTIGATION LOT NUMBER IS UNK. THE DEVICE WAS NOT RETURNED. IMAGES WERE NOT PROVIDED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE FOR FILTER TILT AND MIGRATION. BASED UPON THE AVAILABLE INFO, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNK. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS/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 DIAMETERS 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. FILTER TILT. FILTER MALPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX ONE WEEK POST VENA CAVA FILTER DEPLOYMENT, A CT SCAN DEMONSTRATED A FILTER TILT, AND THE FILTER WAS NOTED TO HAVE MIGRATED IN A CEPHALAD DIRECTION APPROX TWO TO THREE CM. THE CT SCAN WAS PERFORMED FOR AN UNRELATED ISSUE AND THE FINDINGS WERE INCIDENTAL. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298036 MERIDIAN FILTER SYSTEM- FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1