BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALN OPTIONAL VENA CAVA FILTER

    MDR report key: 2857744 · Received November 15, 2012

    Report

    Report Number
    3007080617-2012-00003
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    April 1, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ALN
    Product Code
    DTK
    PMA / PMN Number
    K070514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POSITION OF RUPTURE AND THE FACT THAT THE FILTER IS NOT DEFORMED IN MEDICAL IMAGES INDICATE THAT THE RUPTURE IS PROBABLY DUE TO A MANIPULATION OF THE FILTER AFTER ITS IMPLANTATION BETWEEN 2002 AND 2012 (TENTATIVE OF RETRIEVAL BY THE LEG OR CUT DURING ANOTHER INTERVENTION). AS THE MANUFACTURER HAS NO ACCESS TO THE MEDICAL FILE OF THE PT, THE REAL CAUSE TO THE RUPTURE CANNOT BE ASSESS DEFINITIVELY.

    Description of Event or Problem · 1

    IN (B)(6) 2002 A CAVAL FILTER WAS IMPLANTED IN A PT FOR RECURING DEEP VEIN THROMBOSIS. IN (B)(6) 2012 THERE WAS A SECOND EPISODE OF LEFT BASAL EMBOLISM AND AFTER TESTS AND A CONTROL IT WAS FOUND THAT THE FILTER WAS FRACTURED. PRESENCE OF A LEG OF THE FILTER NEAR THE LEFT VENTRICULE. PT IS ASYMPTOMATIC. CT SCAN CONTROL HAVE BEEN MADE, RESULTS ARE UNKNOWN BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALN OPTIONAL VENA CAVA FILTER OPTIONAL VENA CAVA FILTER DTK ALN FJ.120096 1201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other