BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 4874530 · Received June 29, 2015

    Report

    Report Number
    9616099-2015-00256
    Event Type
    Injury
    Date Received
    June 29, 2015
    Date of Event
    May 1, 2015
    Report Date
    July 6, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). LITERATURE CITATION: LAVAN ET AL (2015). THE USE OF OPTIONAL INFERIOR VENA CAVA FILTERS OF TYPE OPTEASE IN TRAUMA-PATIENTS- A SINGLE TYPE OF FILTER IN A SINGLE MEDICAL CENTER. THROMBOSIS RESEARCH, 135, 873-876. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. DUE TO THE TYPE OF COMPLAINT, THE EVENT DATE IS NOT ACCURATE.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION:AS NOTED IN A LITERATURE PUBLICATION, THE USE OF OPTEASE IVC FILTERS IN A SINGLE MEDICAL CENTER, THREE PATIENTS WERE DIAGNOSED WITH IVC THROMBOSIS FOLLOWING CAVOGRAPHY IN THE RADIOLOGY SUITE JUST BEFORE PLANNING TO REMOVE THE FILTER. A SECOND ATTEMPT TO REMOVE THE OPTEASE FILTER WAS MADE AFTER INCREASING THE DOSE OF LMWH TO A THERAPEUTIC DOSE. IN ONLY ONE PATIENT¿S REMOVAL OF THE FILTER WAS POSSIBLE AT THE SECOND ATTEMPT. THE STUDY EVALUATED COMPLICATIONS RELATED TO A SINGLE TYPE OF FILTER PROPHYLACTICALLY USED IN A TERTIARY TRAUMA CENTER AND SEARCH FOR RISK FACTORS THAT MAY PRECLUDE FILTER RETRIEVAL. 142 PATIENTS AGED 16 THROUGH 60 WHO EXPERIENCED A MAJOR TRAUMA AND WERE TREATED WITH A PROPHYLACTIC IVC FILTER OF TYPE OPTEASE WERE EVALUATED. THE MEDIAN TIME FROM TRAUMA TO FILTER INSERTION WAS 2 DAYS AND LOW MOLECULAR WEIGHT HEPARIN AT PROPHYLACTIC DOSE WAS INITIATED IN 92% ONCE THE FILTER WAS INSERTED. PRODUCT FILE (B)(4): DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE WAS NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBER PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. 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. 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 REPORTED ¿RETRIEVAL DIFFICULTY-UNABLE TO RETRIEVE FROM VESSEL WALL¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS NOR WERE PROCEDURAL FILMS PROVIDED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THE EXACT CAUSE COULD NOT BE DETERMINED AND THERE IS NO INDICATION THAT THE RETRIEVAL DIFFICULTY COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY LAVAN ET AL THE USE OF OPTIONAL INFERIOR VENA CAVA FILTERS OF TYPE OPTEASE IN TRAUMA-PATIENTS- A SINGLE TYPE OF FILTER IN A SINGLE MEDICAL CENTER, IN 3 PATIENTS, WHO WERE DIAGNOSED WITH IVC THROMBOSIS FOLLOWING CAVOGRAPHY AT THE RADIOLOGY SUITE JUST BEFORE PLANNING TO REMOVE THE FILTER, A SECOND ATTEMPT TO REMOVE THE OPTEASE FILTER WAS MADE AFTER INCREASING THE DOSE OF LMWH TO A THERAPEUTIC DOSE. IN ONLY ONE PATIENT REMOVAL OF THE FILTER WAS POSSIBLE AT THE SECOND ATTEMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418014 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS CORPORATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1