BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMON NITINOL FILTER

    MDR report key: 1993063 · Received February 10, 2011

    Report

    Report Number
    MW5019407
    Event Type
    Injury
    Date Received
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BARD
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BARD SIMON NITINOL FILTER PLACED IN IVC ON (B)(6) 2004 WITHOUT COMPLICATION. PT RETURNED IN 2009 FOR ANOTHER ISSUE AND WAS FOUND ON CT SCAN OF ABDOMEN TO HAVE A FRAGMENTED FILTER. ONE STRUT WAS OUTSIDE THE IVC IN THE AREA OF THE RIGHT RENAL HILUM, COMPLETELY DETACHED FROM THE FILTER. LACKING THAT STRUT, THE FILTER HAD MOVED PROXIMALLY AND WAS PARTIALLY IN THE RIGHT RENAL VEIN. THE PT IS NOW (B)(6) AND NO KNOWN CLINICAL PROBLEM RESULTED FROM THE FILTER FRACTURE, SO IT REMAINS IN PLACE. NO EMBOLIZATION OF FILTER FRAGMENTS TO LUNG APPARENT. FILTER SERIAL NUMBER (B)(4). DATES OF USE: (B)(6) 2004 - (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: DVT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMON NITINOL FILTER NONE DTK BARD 07GN1198

    Patients

    Seq Age Sex Outcome Treatment
    1 Other