BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2864581 · Received December 10, 2012

    Report

    Report Number
    9616099-2012-00738
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 1, 2008
    Report Date
    November 16, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE MEDWATCH REPORTS WHICH IS ASSOCIATED WITH THIS LITERATURE ARTICLE AND ASSOCIATED WITH MFG. REPORT # 9616099-2012-00738, 9616099-2012-00739, AND 9616099-2012-00740.

    Additional Manufacturer Narrative · 1

    KUN ET AL COMPLICATIONS BETWEEN ZQL-TYPE AND IMPORTED OPTEASE VENA CAVA FILTER. JOURNAL OF CHINA MEDICAL UNIVERSITY. 37(5). OCT 2008. 641-643; REPORT WHILE THERE WERE CASES OF TWO THROMBUS INSIDE THE FILTER, EIGHT DEEP VENA THROMBOSIS, EIGHT OBSTRUCTION OF INFERIOR VENA CAVA, ONE ORMOND'S SYNDROME AND ONE PULMONARY EMBOLISM INVOLVING THE OPTEASE FILTERS. OBJECTIVE TO EVALUATE THE CLINICAL VALUE OF THE HOME-MADE ZQL-TYPE VENA CAVA FILTER BY COMPARING POST-IMPLANTATIONS COMPLICATIONS BETWEEN THE HOME- MADE ZQL-TYPE VENA CAVA FILTER AND IMPORTED OPTEASE VENA CAVA FILTER. METHODS THE CASES WITH HOME-MADE FILTER WERE NAMED GROUP 1 AND THE CASES WITH IMPORTED FILTER GROUP II. THE ABDOMINAL X-RAY PLANE GRAPH, ANGIOGRAPHY OF PULMONARY ARTERY AND ULTRASONOGRAPHY WERE CONDUCTED AFTER THE OPERATION. AND CT WAS PERFORMED TO DOUBTFUL PULMONARY EMBOLISM. RESULTS THERE WERE ONE FILTER MIGRATION (>10 CM), ONE THROMBUS INSIDE THE FILTER, TWO DEEP VENA THROMBOSIS, TWO OBSTRUCTION OF INFERIOR VENA CAVA AND ONE PULMONARY EMBOLISM IN GROUP 1. WHILE THERE WERE TWO THROMBUS INSIDE THE FILTER, EIGHT DEEP VENA THROMBOSIS, EIGHT OBSTRUCTION OF INFERIOR VENA CAVA, ONE ORMOND'S SYNDROME AND ONE PULMONARY EMBOLISM IN GROUP II. CONCLUSION THERE IS NO SIGNIFICANT DIFFERENCE IN COMPLICATIONS OF POST-OPERATION BETWEEN THE HOME-MADE ZQL-TYPE VENA CAVA FILTER AND THE IMPORTED OPTEASE FILTER. A COPY OF THE FULL ARTICLE COULD NOT BE OBTAINED AT THIS TIME. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. IT IS UNKNOWN FROM THE ABSTRACT IF THE INFERIOR VENA CAVA THROMBUS AND OCCLUSIONS INVOLVED THE DEPLOYED FILTERS OR NOT. IN THESE CASES IT CAN BE ASSUMED THAT IT DID NOT INVOLVE THE FILTER AS THE ABSTRACT SPECIFICALLY CALLS OUT THE THROMBUS IN THE FILTER AS SEPARATE EVENTS. AS SUCH, IN THIS CASE, THROMBUS IN, AND OCCLUSION OF, THE INFERIOR VENA CAVA IS LIKELY RELATED TO THE PATIENT DEVELOPING DVT WHICH HAS TRAVELLED TO AND IS INVOLVING 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. THE PURPOSE OF A VENA CAVA FILTER IS TO CATCH THROMBUS FROM THE LOWER EXTREMITIES AS IT TRAVELS ALONG NORMAL BLOOD FLOW PATTERNS UP TOWARDS THE HEART. THROMBUS IN THE FILTER DOES NOT REPRESENT A DEVICE MALFUNCTION. THROMBOSIS IN THE FILTER IS A WELL KNOWN POTENTIAL COMPLICATION AND OCCURS IN APPROXIMATELY 3.6 TO 11.2 % OF ALL PATIENTS. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION. INFERIOR VENA CAVA FILTERS ARE USED TO PREVENT 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. CURRENT EVIDENCE INDICATES THAT IVC FILTERS ARE LARGELY EFFECTIVE; BREAKTHROUGH PE OCCURS IN ONLY 0% TO 6.2% OF CASES. WHEN USED APPROPRIATELY, IVC FILTERS ARE A SAFE AND EFFECTIVE METHOD OF PREVENTING PE. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT OR FILMS OF THE PROCEDURE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICES AND THE EVENTS. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. 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. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE MEDWATCH REPORTS WHICH IS ASSOCIATED WITH THIS LITERATURE ARTICLE AND ASSOCIATED WITH MFG. REPORT # 9616099-2012-00738, 9616099-2012-00739, AND 9616099-2012-00740.

    Description of Event or Problem · 1

    KUN ET AL COMPLICATIONS BETWEEN ZQL-TYPE AND IMPORTED OPTEASE VENA CAVA FILTER. JOURNAL OF (B)(6). 37(5). OCT 2008. 641-643; REPORT WHILE THERE WERE CASES OF TWO THROMBUS INSIDE THE FILTER, EIGHT DEEP VENA THROMBOSIS, EIGHT OBSTRUCTION OF INFERIOR VENA CAVA, ONE ORMOND'S SYNDROME AND ONE PULMONARY EMBOLISM INVOLVING THE OPTEASE FILTERS. OBJECTIVE TO EVALUATE THE CLINICAL VALUE OF THE HOME-MADE ZQL-TYPE VENA CAVA FILTER BY COMPARING POST-IMPLANTATION COMPLICATIONS BETWEEN THE HOME- MADE ZQL-TYPE VENA CAVA FILTER AND IMPORTED OPTEASE VENA CAVA FILTER. METHODS THE CASES WITH HOME-MADE FILTER WERE NAMED GROUP 1 AND THE CASES WITH IMPORTED FILTER GROUP II. THE ABDOMINAL X-RAY PLANE GRAPH, ANGIOGRAPHY OF PULMONARY ARTERY AND ULTRASONOGRAPHY WERE CONDUCTED AFTER THE OPERATION. AND CT WAS PERFORMED TO DOUBTFUL PULMONARY EMBOLISM. RESULTS THERE WERE ONE FILTER MIGRATION (>10 CM), ONE THROMBUS INSIDE THE FILTER, TWO DEEP VENA THROMBOSIS, TWO OBSTRUCTION OF INFERIOR VENA CAVA AND ONE PULMONARY EMBOLISM IN GROUP 1. WHILE THERE WERE TWO THROMBUS INSIDE THE FILTER, EIGHT DEEP VENA THROMBOSIS, EIGHT OBSTRUCTION OF INFERIOR VENA CAVA, ONE ORMOND'S SYNDROME AND ONE PULMONARY EMBOLISM IN GROUP II. CONCLUSION THERE IS NO SIGNIFICANT DIFFERENCE IN COMPLICATIONS OF POST-OPERATION BETWEEN THE HOME-MADE ZQL-TYPE VENA CAVA FILTER AND THE IMPORTED OPTEASE FILTER.

    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