BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENAI FERMORAL SYSTEM

    MDR report key: 4213261 · Received October 3, 2014

    Report

    Report Number
    2020394-2014-00442
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 6, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K130366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING REVIEW COULD NOT BE CONDUCTED AS THE INVESTIGATION LOT NUMBER IS UNKNOWN. THE DEVICE WAS NOT RETURNED. IMAGES WERE PROVIDED. THE IMAGES IDENTIFIED TWO DENALI FILTERS PROJECTED AT THE RIGHT SIDE OF THE SPINE. ALL TWELVE FILTER LIMBS OF THE FILTER IN THE INFERIOR POSITION ARE NOT COMPLETELY EXPANDED. THE PLACEMENT LEVEL OF THE FILTERS CANNOT BE DETERMINED FROM THE IMAGE PROVIDED, AND THERE IS NO REFERENCE IMAGE FROM WHICH TO DETERMINE IF THE INITIALLY PLACED FILTER IS BELOW THE INTENDED PLACEMENT SITE. BASED ON THE IMAGE PROVIDED, FAILURE OF THE ENTIRE FILTER TO COMPLETELY EXPAND CAN BE CONFIRMED. CAUDAL MIGRATION CANNOT BE CONFIRMED. THEREFORE, BASED ON THE IMAGE PROVIDED, FAILURE OF THE ENTIRE FILTER TO COMPLETELY EXPAND CAN BE CONFIRMED. CAUDAL MIGRATION CANNOT BE CONFIRMED. THEREFORE, BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. IT IS UNKNOWN IF PROCEDURAL FACTORS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON DEPLOYMENT OF A VENA CAVA FILTER, THE FILTER LIMBS DID NOT FULLY EXPAND AND THE FILTER MIGRATED CAUDALLY. THE FILTER WAS NOT RETRIEVED AND A SECOND FILTER WAS IMPLANTED SUPERIOR TO IT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620448 DENAI FERMORAL SYSTEM DTK BARD PERIPHERAL VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female Required Intervention NORVASC, IRON, BETA BLOCKER