BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEASE PERMANENT VENA CAVA FILTER 55CM

    MDR report key: 1061491 · Received June 16, 2008

    Report

    Report Number
    9610978-2008-00149
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 28, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DQO
    PMA / PMN Number
    K020316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STRUT FRACTURES ARE A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THIS TYPE OF PROCEDURE. THE AORTA IS A DYNAMIC VESSEL CREATING VARIOUS FORCES; ANGULATION, STRETCHING AND COMPRESSION, THAT COULD LEAD TO STRESS UPON THE FILTER AND TO STRUT FRACTURE. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND ALTHOUGH A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER, THERE IS NO INDICATION FROM THE INFORMATION AT HAND THAT THIS EVENT WAS DESIGN OR MANUFACTURING RELATED.

    Description of Event or Problem · 1

    APPROXIMATELY THREE YEARS POST FILTER IMPLANTATION, THE TRAPEASE VENA CAVA FILTER WAS NOTED TO HAVE A STRUT FRACTURE. THE TRAPEASE WAS IMPLANTED BELOW THE RENAL VEINS WITHOUT REPORTED ADVERSE EVENTS. THE PATIENT WAS A FEMALE WITH HISTORY OF DVT, RECURRENT PULMONARY EMBOLISM, AND ANTI-COAGULANT THERAPY. ON AN X-RAY OF THE LUMBER SPINE, IT WAS NOTED THAT THE TRAPEASE HAD A SINGLE STRUT FRACTURE. THERE WERE NO INTERVENTIONS REQUIRED, NO TREATMENTS PERFORMED AND THE PATIENT HAS HAD NO REPORTED INJURIES. THE PRODUCT REMAINS IMPLANTED AND UNAVAILABLE FOR ANALYSIS. NO STERILE LOT NUMBER WAS AVAILABLE, THE PRODUCT REMAINS IMPLANTED, AND THEREFORE NO DEVICE HISTORY RECORD REVIEW COULD BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEASE PERMANENT VENA CAVA FILTER 55CM THROMBECTOMY SYSTEMS (DQO) DQO CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR