BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2870696 · Received December 12, 2012

    Report

    Report Number
    9616099-2012-00741
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    February 1, 2011
    Report Date
    November 16, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE: HUSEYIN S., GURKAN S., GUR O., UNAL S., CANBAZ S., EGE T., SUNGUN M. (2011, FEBRUARY). HEART SURGERY FORUM; 7TH INTERNATIONAL CONGRESS OF UPDATE IN CARDIOLOGY, PAGE 14. THIS MDR REPORT IS BEING SUBMITTED FOR TWO PATIENTS WITH NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED VIA A LITERATURE REVIEW, DEEP VENOUS THROMBOSIS IS THE CAUSE OF MORBIDITY AND MORTALITY. VENA CAVA FILTER IS A TREATMENT OPTION IN PATIENTS THAT CANNOT BE TREATED BY ANTICOAGULANT OR THROMBOLYTIC FOR PREVENTING PULMONARY EMBOLISM. IN OUR CLINIC, WE FOCUSED ON CLINICAL OUTCOMES OF PATIENTS THAT VENA CAVA FILTER IS USED. METHODS: BETWEEN JANUARY 2007 AND DECEMBER 2010 WE USED VENA CAVA FILTER (CORDIS OPTEASE BY JOHNSON & JOHNSON COMPANY, USA) IN 12 PATIENTS WHO HAVE DEEP VENOUS THROMBOSIS. AT THE SAME TIME THEY CANNOT BE TREATED BY ANTICOAGULANT THERAPY BECAUSE OF THEIR CLINICAL CONDITION. THIS PROCEDURE IS PERFORMED WITH LOCAL ANESTHESIA UNDER SCOPY DEVICE BY REPLACING THE FILTER UNDER RENAL VEINS. PROCEDURE WAS ESTABLISHED VIA FEMORAL VEIN. RESULTS: MEAN AGE OF 12 PATIENTS WERE (B)(6). DURING THE PROCEDURE IN 1 PATIENT FILTER WAS REPLACED TO RIGHT ATRIUM. FOLLOWING THIS, FILTER WAS TAKEN AND IT WAS AGAIN REPLACED TO INFRARENAL LOCATION. IN OTHER PATIENTS, THERE WERE NO COMPLICATIONS DURING THIS PROCEDURE. 5 PATIENTS IMPROVED CLINICALLY AND RADIOLOGICALLY. FOR 2 OF THEM, WE PLANNED DISPLACEMENT OF FILTER AFTER ONE MONTH. HOWEVER, BECAUSE OF THE DYSFUNCTION OF A FILTER COMPONENT, DISPLACEMENT COULD NOT BE DONE. OTHER 3 PATIENT'S FOLLOW UP IS STILL CONTINUING. CONCLUSIONS: FOR THE PATIENTS WHO HAVE PULMONARY EMBOLISM AND CANNOT BE TREATED BY ANTICOAGULANT TREATMENT, VENA CAVA FILTER IS AN EFFECTIVE METHOD FOR PREVENTION OF IMPORTANT COMPLICATIONS. ALTHOUGH THIS TECHNIQUE IS NOT USED FREQUENTLY, WE CONSIDER THAT IT CAN BE USED CONFIDENTLY IN MANY PATIENTS. THE COMPLAINT DEVICES ARE UNAVAILABLE FOR ANALYSIS. THERE WAS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHRS COULD BE PERFORMED. IVC FILTER MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IVC FILTER IMPLANTATION AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. MIGRATION OF IVC FILTERS HAS BEEN DEMONSTRATED WHEN THE PRESENCE OF AN OVERBURDEN OF THROMBUS IN THE VASCULATURE OCCURS THAT EXCEEDS THE DEVICES ABILITY TO EXERT RADIAL FORCE TOWARD THE VESSEL WALLS AND MAINTAIN OPTIMAL POSITIONING. WITHOUT STERILE LOT NUMBER INFORMATION, THE DHRS COULD NOT BE REVIEWED; HOWEVER, EACH PRODUCT IS INSPECTED PRIOR TO RELEASE FOR MARKETING AND ANY UNIT THAT DOES NOT MEET SPECIFICATIONS IS SEGREGATED AND DESTROYED. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE AVAILABLE INFORMATION DOES NOT SUGGEST WHAT POTENTIAL CONTRIBUTING FACTORS MAY HAVE BEEN INVOLVED IN THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    AS REPORTED VIA A LITERATURE REVIEW, DEEP VENOUS THROMBOSIS IS THE CAUSE OF MORBIDITY AND MORTALITY ABOUT ITS COMPLICATIONS. VENA CAVA FILTER IS A TREATMENT OPTION IN PATIENTS THAT CANNOT BE TREATED BY ANTICOAGULANT OR THROMBOLYTIC FOR PREVENTING PULMONARY EMBOLISM. IN OUR CLINIC, WE FOCUSED ON CLINICAL OUTCOMES OF PATIENTS THAT VENA CAVA FILTER IS USED. METHODS: BETWEEN (B)(6) 2007 AND (B)(6) 2010, WE USED VENA CAVA FILTER (CORDIS OPTEASE BY JOHNSON & JOHNSON COMPANY, USA) IN 12 PATIENTS WHO HAVE DEEP VENOUS THROMBOSIS. AT THE SAME TIME THEY CANNOT BE TREATED BY ANTICOAGULANT THERAPY BECAUSE OF THEIR CLINICAL CONDITION. THIS PROCEDURE IS PERFORMED WITH LOCAL ANESTHESIA UNDER SCOPY DEVICE BY REPLACING THE FILTER UNDER RENAL VEINS. PROCEDURE WAS ESTABLISHED VIA FEMORAL VEIN. RESULTS: MEAN AGE OF (B)(6) PATIENTS WERE (B)(6). DURING THE PROCEDURE IN (B)(6) PATIENT FILTER WAS REPLACED TO RIGHT ATRIUM. FOLLOWING THIS, FILTER WAS TAKEN AND IT WAS AGAIN REPLACED TO INFRARENAL LOCATION. IN OTHER PATIENTS, THERE WERE NO COMPLICATIONS DURING THIS PROCEDURE. (B)(6) PATIENTS IMPROVED CLINICALLY AND RADIOLOGICALLY. FOR (B)(6) OF THEM, WE PLANNED DISPLACEMENT OF FILTER AFTER ONE MONTH. HOWEVER BECAUSE OF THE DYSFUNCTION OF A FILTER COMPONENT, DISPLACEMENT COULD NOT BE DONE. OTHER (B)(6) PATIENT'S FOLLOW UP IS STILL CONTINUING. CONCLUSIONS: FOR THE PATIENTS WHO HAVE PULMONARY EMBOLISM AND CANNOT BE TREATED BY ANTICOAGULANT TREATMENT, VENA CAVA FILTER IS AN EFFECTIVE METHOD FOR PREVENTION OF IMPORTANT COMPLICATIONS. ALTHOUGH THIS TECHNIQUE IS NOT USED FREQUENTLY, WE CONSIDER THAT IT CAN BE USED CONFIDENTLY IN MANY PATIENTS.

    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 Life Threatening