BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE FILTER

    MDR report key: 1924827 · Received December 14, 2010

    Report

    Report Number
    9610978-2010-00259
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    AT AN UNKNOWN TIME POST VENA CAVA FILTER PLACEMENT THE PATIENT WAS NOTED BY DOPPLER ULTRASOUND TO HAVE BILATERAL DEEP VEIN THROMBOSIS EXTENDING INTO THE IVC UP TO THE LEVEL OF THE TRAPEASE FILTER SITE. THE IVC ABOVE THE FILTER WAS PATENT. INITIAL DEPLOYMENT DETAILS ARE UNKNOWN AS THE FILTER WAS PLACED AT A DIFFERENT FACILITY. IT WAS STATED THAT THE PATIENT DEVELOPED THE DVT AFTER STOPPING COUMADIN FOR 4 DAYS SECONDARY TO A SURGICAL PROCEDURE. MECHANICAL ASPIRATION THROMBECTOMY PERFORMED WITH RECANALIZATION OF VENOUS FLOW IN LOWER EXTREMITIES AND ILIAC VEINS. THE IVC WAS PARTIALLY RECANALIZED AS THE ANGIOJET THROMBECTOMY SYSTEM CANNOT FULLY ASPIRATE THE CLOT OF A LARGE VESSEL CALIBER LIKE THE IVC. THROMBOLYTIC THERAPY WAS NOT AN OPTION SINCE RECENT SURGERY HAD BEEN PERFORMED. CLINICALLY THE PATIENT IMPROVED. THE RECOMMENDATION WAS NOT TO ATTEMPT FILTER RETRIEVAL AND AGGRESSIVE ANTICOAGULATION WAS INSTRUCTED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. IT IS RECOGNIZED THAT THROMBI USUALLY DEVELOP FIRST IN THE CALF VEINS, "GROWING" IN THE DIRECTION OF FLOW OF THE VEIN. DVTS ARE DISTINGUISHED AS BEING ABOVE OR BELOW THE POPLITEAL VEIN. VERY EXTENSIVE DVTS CAN EXTEND INTO THE ILIAC VEINS OR THE INFERIOR VENA CAVA. PLACEMENT OF A VENA CAVA FILTER IS NOT A CURE FOR DVT NOR DOES IT PREVENT THE FORMATION OF DVT. INFERIOR VENA CAVA FILTERS ARE USED TO PREVENT SEQUELAE, ESPECIALLY PE, IN PATIENTS WITH CONTRAINDICATIONS TO, COMPLICATIONS OF, OR FAILURE OF ANTICOAGULATION THERAPY AND PATIENTS WITH EXTENSIVE FREE-FLOATING THROMBI OR RESIDUAL THROMBI FOLLOWING MASSIVE PE. PLACEMENT OF A VENA CAVA FILTER REDUCES, BUT DOES NOT ELIMINATE THE RISK OF SYMPTOMATIC PE IN PATIENTS WITH PROXIMAL DVT IN THE SHORT-TERM AND DOES NOT PREVENT SMALL PE. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMITTED WITH DEEP VEIN THROMBOSIS, FIVE DAYS LATER, THE PATIENT WAS FOUND TO HAVE THROMBOSIS SEATING ABOVE THE TRAPEASE FILTER. THE PATIENT DOES NOT KNOW WHEN THE FILTER WAS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE DEEP VEIN THROMBOSIS (DVT) WAS DIAGNOSED WITH DOPPLER ULTRASOUND. THERE WAS BILATERAL DVT OF THE LOWER EXTREMITIES EXTENDING INTO THE INFERIOR VENA CAVA (IVC) UP TO LEVEL OF THE TRAPEASE FILTER SITE. IVC ABOVE THE FILTER WAS PATENT. THE SIZE OF THE VENA CAVA WAS 24MM. THERE WERE NO PERI OR POST PROCEDURAL COMPLICATIONS. THERE WAS NO PATIENT INJURY. INITIAL DEPLOYMENT DETAILS ARE UNKNOWN AS THE FILTER WAS PLACED AT A DIFFERENT FACILITY. IT WAS STATED THAT THE PATIENT DEVELOPED THE DVT AFTER STOPPING COUMADIN FOR 4 DAYS SECONDARY TO A SURGICAL PROCEDURE. MECHANICAL ASPIRATION THROMBECTOMY PERFORMED WITH RECANALIZATION OF VENOUS FLOW IN LOWER EXTREMITIES AND ILIAC VEINS. THE IVC WAS PARTIALLY RECANALIZED AS THE ANGIOJET THROMBECTOMY SYSTEM CANNOT FULLY ASPIRATE THE CLOT OF A LARGE VESSEL CALIBER LIKE THE IVC. THROMBOLYTIC THERAPY WAS NOT AN OPTION SINCE RECENT SURGERY HAD BEEN PERFORMED. CLINICALLY THE PATIENT IMPROVED. THE RECOMMENDATION...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEASE FILTER THROMBECTOMY SYSTEMS (DQO) DTK CORDIS EUROPA, N.V. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L