BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    466FXXXX

    MDR report key: 8013761 · Received October 29, 2018

    Report

    Report Number
    9616099-2018-02468
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    August 14, 2018
    Report Date
    October 29, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE.  THE DEVICE IS AN UNKNOWN FILTER AND THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE.  KOIZUMI, J., HARA, T., SEKIGUCHI, T., ICHIKAWA, T., TAJIMA, H., TAKENOSHITA, N., SHIRATO, K. (2018). MULTICENTER INVESTIGATION OF THE INCIDENCE OF INFERIOR VENA CAVA FILTER FRACTURE. JAPANESE JOURNAL OF RADIOLOGY, 36(11), 661-668. DOI:10.1007/S11604-018-0764-X AS NOTED IN THE PUBLICATION BY KOIZUMI ET AL., MULTICENTER INVESTIGATION OF THE INCIDENCE OF INFERIOR VENA CAVA FILTER FRACTURE; JPN J RADIOL. 2018 AUG 14. DOI: 10.1007/S11604-018-0764-X; THERE WAS ONE CASE OF AN OPTEASE FILTER FRACTURE ONE THOUSAND, SIX-HUNDRED AND FIFTY DAYS POST IMPLANTATION. THE FRACTURED STRUT IS LOCATED IN THE AORTA/SUPERIOR. NO MIGRATION OF THE FRACTURED STRUT HAS OCCURRED. THE FILTER WAS IMPLANTED IN THE INFRARENAL POSITION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE STERILE LOT NUMBER HAS NOT BEEN PROVIDED; THEREFORE, NO DEVICE ANALYSIS NOR DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. THE INFERIOR VENA CAVA (IVC) FILTER IS INDICATED FOR USE IN THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PERCUTANEOUS PLACEMENT IN THE VENA CAVA FOR PATIENTS IN WHICH ANTICOAGULANTS ARE CONTRAINDICATED, ANTICOAGULANT THERAPY FOR THROMBOEMBOLIC DISEASE HAS FAILED, EMERGENCY TREATMENT FOLLOWING MASSIVE PULMONARY EMBOLISM WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED OR FOR CHRONIC, RECURRENT PULMONARY EMBOLISM WHERE ANTICOAGULANT THERAPY HAS FAILED, OR IS CONTRAINDICATED. 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. WITHOUT THE LIMITED INFORMATION PROVIDED, THE EXACT CAUSE OF THE REPORTED ¿FILTER- FRACTURED-SEPARATED - IN PATIENT¿ COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) STATES FILTER FRACTURE IS A POTENTIAL COMPLICATION OF VENA CAVA FILTERS. ANATOMIC LOCATIONS THAT CREATE CONCENTRATED STRESS POINTS FROM FILTER DEFORMATION (FOR EXAMPLE, DEPLOYMENT AT APEX OF SCOLIOSIS, OVERLAPPING OF EITHER OF THE RENAL OSTIA, OR PLACEMENT ADJACENT TO A VERTEBRAL OSTEOPHYTE) MAY CONTRIBUTE TO FRACTURE OF A PARTICULAR FILTER STRUT. ALSO, WITH THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN AND/OR MANUFACTURING PROCESS OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY KOIZUMI ET AL., MULTICENTER INVESTIGATION OF THE INCIDENCE OF INFERIOR VENA CAVA FILTER FRACTURE; JPN J RADIOL. 2018 AUG 14. DOI: 10.1007/S11604-018-0764-X; THERE WAS ONE CASE OF AN OPTEASE FILTER FRACTURE ONE THOUSAND, SIX-HUNDRED AND FIFTY DAYS POST IMPLANTATION. THE FRACTURED STRUT IS LOCATED IN THE AORTA/SUPERIOR. NO MIGRATION OF THE FRACTURED STRUT HAS OCCURRED. THE FILTER WAS IMPLANTED IN THE INFRARENAL POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854612 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CASHEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR