BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECOVERY FILTER SYSTEM

    MDR report key: 1213200 · Received October 22, 2008

    Report

    Report Number
    2020394-2008-00292
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    November 16, 2007
    Report Date
    October 2, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K031328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNKNOWN. THE RESULT OF THE INVESTIGATION WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. THE CURRENT IFU (INSTRUCTIONS FOR USE) FOR THIS DEVICE STATES: POTENTIAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: FILTER FRACTURE. FILTER FRACTURE IS A KNOWN COMPLICATION OF VENA CAVA FILTERS, THERE HAVE BEEN SOME REPORTS OF EMBOLIZATION OF VENA CAVA FILTER FRAGMENTS RESULTING IN RETRIEVAL OF THE FRAGMENT USING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. MOST CASES, HOWEVER, HAVE BEEN REPORTED WITHOUT ANY ADVERSE CLINICAL SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IVC FILTER WAS PLACED THREE YEARS, FIVE MONTHS (PRIOR TO REMOVAL)AS A PROPHYLACTIC EFFORT, DUE TO PROLONGED BEDREST DURING TREATMENT OF A STERNAL WOUND INFECTION, POST CORONARY ARTERY BYPASS GRAFT (CABG). A CT OF THE CHEST ON THE DAY OF REMOVAL, REVEALED THE IVC FILTER TO BE PRESENT, BUT A FRACTURED ARM WAS NOTED IN THE PT'S RIGHT UPPER LOBE. THE PERIPHERAL MARGIN OF THE FRAGMENT IS LESS THAN 1 CM FROM THE PLEURA. REMOVAL OF THE DEVICE WAS UNEVENTFUL, AND THE PT WAS DISCHARGED HOME THE DAY OF REMOVAL. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR