BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2183058 · Received July 28, 2011

    Report

    Report Number
    9616099-2011-00555
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 16, 2010
    Report Date
    July 12, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPORT FROM A JOURNAL ARTICLE (DOTAN ET AL IN OPTEASE VENA CAVA FILTER OPTIMAL INDWELLING TIME AND RETRIEVABILITY CARDIOVASC INTERVENT RADIOL (2011)) STATES THAT A FILTER COULD NOT BE REMOVED BECAUSE OF LARGE THROMBUS IN THE FILTER (>1CM AS MEASURED ON THE CALIBRATED VENOGRAPHY), AND RETRIEVAL WAS NOT ATTEMPTED. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE INDWELLING TIME AND RETRIEVABILITY OF THE OPTEASE IVC FILTER. BETWEEN 2002 AND 2009, A TOTAL OF 811 OPTEASE FILTERS WERE INSERTED: 382 FOR PROPHYLAXIS IN MULTITRAUMA PATIENTS AND 429 FOR PATIENTS WITH VENOUS THROMBO-EMBOLIC (VTE) DISEASE. IN 139 PATIENTS [97 MEN AND 42 WOMEN; MEAN AGE, 36 (RANGE, 17-82) YEARS], FILTER RETRIEVAL WAS ATTEMPTED. FROM (B)(6) 2002 TO (B)(6) 2009, 811 OPTEASE FILTERS WERE INSERTED IN A SINGLE TERTIARY CARE INSTITUTION: 382 FILTERS FOR PROPHYLAXIS IN MULTITRAUMA PATIENTS, AND 429 FOR PATIENTS WITH VTE DISEASE, WHO WERE ANTICOAGULATION TREATMENT FAILURES OR WHO HAD CONTRAINDICATIONS TO ANTICOAGULATION. FILTERS INSERTED AS A PROPHYLAXIS IN TRAUMA PATIENTS WERE INTENDED TO RETRIEVE IN ALL PATIENTS YOUNGER THAN AGE 60 YEARS. THE PHYSICIANS ARBITRARILY DECIDED NOT TO RETRIEVE FILTERS IN PATIENTS OLDER THAN THIS AGE UNLESS THE PATIENT HAS NO OTHER SIGNIFICANT DISEASES. A TOTAL OF 164 PATIENTS WERE REFERRED FOR FILTER REMOVAL, WHILE THERE WAS NO LONGER A NEED FOR IT NOR WAS THERE ANY MORE CONTRAINDICATION FOR ANTICOAGULATION. ANTICOAGULATION THERAPY WAS GIVEN ONLY TO THOSE PATIENTS WITH PROVEN VTE. TWENTY-FIVE FILTERS WERE NOT REMOVED BECAUSE OF LARGE THROMBUS IN THE FILTER (1 CM AS MEASURED ON THE CALIBRATED VENOGRAPHY), AND RETRIEVAL WAS NOT ATTEMPTED. THE IFU STATES THAT RETRIEVAL OF THE OPTEASE FILTER SHOULD NOT BE ATTEMPTED IF THROMBUS IS PRESENT IN THE FILTER AND/OR CAUDAL TO THE FILTER. 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. THE PURPOSE OF THE VENA CAVA FILTER IS TO CATCH OR TRAP THROMBI AND TO PREVENT IT FROM TRAVELING TO THE HEART AND LUNGS AND THUS THROMBOSIS IN THE FILTER AND IS A WELL KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTER INSERTION. THIS DOES NOT REPRESENT A DEVICE MALFUNCTION. 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. PLEASE NOTE THAT THE FOLLOWING TWENTY-FIVE SERVICE REQUESTS ARE RELATED TO THIS THE SAME EVENT OF A VENA CAVA FILTER THROMBOSIS AND ARE BEING REPORTED TO THE FDA.: (B)(4).

    Additional Manufacturer Narrative · 1

    RIMON, URI ET AL (2010 JUNE 10) OPTEASE VENA CAVA FILTER OPTIMAL INDWELLING TIME AND RETRIEVABILITY. CARDIOVASCULAR INTERVENTIONAL RADIOLOGY (2011) 34:532-535. PLEASE NOTE THAT THE FOLLOWING TWENTY-FIVE SERVICE REQUESTS ARE RELATED TO THIS THE SAME EVENT OF A VENA CAVA FILTER THROMBOSIS AND ARE BEING REPORTED TO THE FDA.: (B)(4). THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A REPORT FROM A JOURNAL ARTICLE (DOTAN ET AL IN OPTEASE VENA CAVA FILTER OPTIMAL INDWELLING TIME AND RETRIEVABILITY CARDIOVASC INTERVENT RADIOL (2011)) STATES THAT THE FILTER COULD NOT BE REMOVED BECAUSE OF LARGE THROMBUS IN THE OPTEASE FILTER (>1CM AS MEASURED ON THE CALIBRATED VENOGRAPHY), AND RETRIEVAL WAS NOT ATTEMPTED. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE INDWELLING TIME AND RETRIEVABILITY OF THE OPTEASE IVC FILTER. BETWEEN 2002 AND 2009, A TOTAL OF 811 OPTEASE FILTERS WERE INSERTED: 382 FOR PROPHYLAXIS IN MULTITRAUMA PATIENTS AND 429 FOR PATIENTS WITH VENOUS THROMBO-EMBOLIC (VTE) DISEASE. IN 139 PATIENTS [97 MEN AND 42 WOMEN; MEAN AGE, 36 (RANGE, 17-82) YEARS], FILTER RETRIEVAL WAS ATTEMPTED. FROM (B)(6) 2002 TO (B)(6) 2009, 811 OPTEASE FILTERS WERE INSERTED IN A SINGLE TERTIARY CARE INSTITUTION: 382 FILTERS FOR PROPHYLAXIS IN MULTITRAUMA PATIENTS, AND 429 FOR PATIENTS WITH VTE DISEASE, WHO WERE ANTICOAGULATION TREATMENT FAILURES OR WHO HAD CONTRAINDICATIONS TO ANTICOAGULATION. FILTERS INSERTED AS A PROPHYLAXIS IN TRAUMA PATIENTS WERE INTENDED TO RETRIEVE IN ALL PATIENTS YOUNGER THAN AGE 60 YEARS. THE PHYSICIANS ARBITRARILY DECIDED NOT TO RETRIEVE FILTERS IN PATIENTS OLDER THAN THIS AGE UNLESS THE PATIENT HAS NO OTHER SIGNIFICANT DISEASES. A TOTAL OF 164 PATIENTS WERE REFERRED FOR FILTER REMOVAL, WHILE THERE WAS NO LONGER A NEED FOR IT NOR WAS THERE ANY MORE CONTRAINDICATION FOR ANTICOAGULATION. ANTICOAGULATION THERAPY WAS GIVEN ONLY TO THOSE PATIENTS WITH PROVEN VTE. TWENTY-FIVE FILTERS WERE NOT REMOVED BECAUSE OF LARGE THROMBUS IN THE FILTER (1 CM AS MEASURED ON THE CALIBRATED VENOGRAPHY), AND RETRIEVAL WAS NOT ATTEMPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R