BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEASE VENA CAVA FILTER

    MDR report key: 2001386 · Received February 25, 2011

    Report

    Report Number
    9610978-2011-00038
    Event Type
    Injury
    Date Received
    February 25, 2011
    Report Date
    January 31, 2011
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    K034050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AN OPTEASE FILTER COULD NOT BE REMOVED DUE TO THROMBUS. THE FILTER WAS PLACED IN THE PATIENT AND THE PATIENT RETURNED FOR FILTER REMOVAL THREE WEEKS LATER. REMOVAL COULD NOT BE PERFORMED BECAUSE THE FILTER, INFERIOR VENA CAVA, AND ILIAC VEINS WERE OCCLUDED WITH THROMBUS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THROMBOSIS IN THE FILTER IS A WELL KNOWN POTENTIAL COMPLICATION AND OCCURS IN APPROXIMATELY 3.6 TO 11.2 % OF ALL PATIENT' AND IS LISTED IN THE IFU AS SUCH. THE IFU ALSO STATES THAT RETRIEVAL OF THE OPTEASE FILTER SHOULD NOT BE ATTEMPTED IF THROMBUS IS PRESENT IN THE FILTER AND/OR CAUDAL TO THE FILTER. 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. DVT OCCURS WHEN A BLOOD CLOT FORMS IN A DEEP VEIN AND IS MOST COMMON IN THE DEEP VEINS OF YOUR LOWER LEG (CALF), AND CAN SPREAD UP TO THE VEINS IN YOUR THIGH. DVT CAN ALSO FIRST DEVELOP IN THE DEEP VEINS IN YOUR THIGH AND, MORE RARELY, IN OTHER DEEP VEINS, SUCH AS THE ONES IN YOUR ARM. DEEP VEIN THROMBOSIS IS THE RESULT OF THREE PRINCIPAL FACTORS : REDUCED OR STAGNANT BLOOD FLOW IN DEEP VEINS (VENOUS STASIS). INJURY TO THE BLOOD VESSEL WALL. AN INCREASE IN THE ACTIVITY OF THOSE SUBSTANCES IN THE BLOOD THAT ARE PART OF THE NORMAL CLOTTING MECHANISM, A CONDITION CALLED HYPERCOAGULABILITY (WHICH MEANS A MORE ACTIVE CLOTTING STATE). 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. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER COULD NOT BE PROVIDED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AN OPTEASE FILTER COULD NOT BE REMOVED DUE TO THROMBUS. THE FILTER WAS PLACED IN THE PATIENT AND THE PATIENT RETURNED FOR FILTER REMOVAL THREE WEEKS LATER. REMOVAL COULD NOT BE PERFORMED BECAUSE THE FILTER, INFERIOR VENA CAVA, AND ILIAC VEINS WERE OCCLUDED WITH THROMBUS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other