BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE PERMANENT VENA CAVA FILTER

    MDR report key: 641962 · Received October 18, 2005

    Report

    Report Number
    9610978-2005-01648
    Event Type
    Injury
    Date Received
    October 18, 2005
    Date of Event
    December 25, 2004
    Report Date
    October 18, 2005
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE AFFILIATE STATES THAT THIS FEMALE PATIENT WAS PRESENTED TO THE INTERVENTIONAL LAB WITH LOWER EXTREMITY EDEMA AND HAD A TRAPEASE VENA CAVA FILTER PLACED ON AUGUST 19TH, 2003. THE PATIENT WAS PLACED ON UROKINASE POST-PROCEDURE FORM AUGUST 19, 2003 TO AUGUST 22, 2003. THERE WAS NO REPORTED PATIENT INJURY. IN 2004 THE PATIENT RETURNED TO THE HOSPITAL FOR A FOLLOW-UP VISIT. AN X-RAY WAS TAKEN AND SHOWED THAT THE FILTER HAD FRACTURED. THERE WAS NO INDICATION OF TRAUMA TO THE VESSEL DUE TO THE FILTER FRACTURE. THE PATIENT WAS NOT TREATED IN ANY WAY FOR THE FILTER FRACTURE. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEASE PERMANENT VENA CAVA FILTER TROMBECTOMY SYSTEMS DTK CORDIS EUROPA, N.V. NA R0503167

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR