BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECOVERY FILTER SYSTEM

    MDR report key: 1213199 · Received October 22, 2008

    Report

    Report Number
    2020394-2008-00293
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    December 17, 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 UNK. 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 TWO YEARS AND ELEVEN MONTHS (PRIOR TO REMOVAL) FOR TREATMENT OF PE. CT OF THE ABDOMEN SEVEN DAYS PRIOR TO REMOVAL, REVEALED THE FILTER TO BE PRESENT, BUT SEVERAL LIMBS EXTENDED THROUGH THE WALL OF THE INFERIOR VENA CAVA. CT OF ABDOMEN ON THE DAY OF THE REMOVAL, REVEALED THE FILTER TO BE PRESENT, BUT A FRACTURE LIMB IS PRESENT POSTERIOR TO THE INFERIOR VENA CAVA WITH THE CEPHALIC TIP ABUTTING THE INFERIOR VENA CAVA WALL. NO PROTRUSION INTO THE INFERIOR VENA CAVA IS APPARENT. REMOVAL OF THE DEVICE WAS UNEVENTFUL AND THE PT WAS DISCHARGED HOME THE DAY OF THE REMOVAL. NO PT INJURY 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 37 YR