BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2841871 · Received November 21, 2012

    Report

    Report Number
    9616099-2012-00683
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    September 15, 2005
    Report Date
    November 6, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. VARIOUS COMPLICATIONS HAVE BEEN REPORTED WITH USE OF RETRIEVABLE IVC FILTERS. THE PREDOMINANT CONCERN IS THE DEVELOPMENT OF ENDOTHELIALIZATION, WHICH WOULD MAKE SUBSEQUENT REMOVAL IMPOSSIBLE. ENDOTHELIALIZATION HAS BEEN SHOWN TO LEAD TO EXPLANTATION PROBLEMS AFTER AS SHORT A PERIOD AS 12 DAYS. INCORRECT ORIENTATION OF THE FILTER IS A KNOWN COMPLICATION FOR FILTER PLACEMENT AS INDICATED IN THE IFU. THE TIMING AND MECHANISM OF THE FILTER TILT REMAINS UNCERTAIN. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    KUMAR ET AL FAILED RETRIEVAL OF POTENTIALLY RETRIEVABLE IVC FILTERS: A REPORT OF TWO CASES; CARDIOVASC INTERVENT RADIOL (2006) 29:126-127. REPORT ON A CASE WHERE 14 DAYS AFTER A TEMPORARY OPTEASE IVC FILTER (CORDIS, (B)(4)) WAS PLACED TO COVER THE PERIOD OF NONANTICOAGULATION WHEN THE PATIENT MIGHT BE AT HIGH RISK OF THROMBOEMBOLISM WHEN ANTICOAGULATION WAS RE-ESTABLISHED, REMOVAL ATTEMPTED VIA THE FEMORAL ROUTE USING THE RECOMMENDED SNARE/SHEATH COMBINATION WAS UNSUCCESSFUL. IT PROVED IMPOSSIBLE TO SNARE THE HOOK AT THE LOWER END OF THE IVC FILTER. ATTEMPTS WERE THEN MADE TO CANNULATE ADJACENT STRUT-GAPS IN THE CAUDAL END OF THE FILTER, WHICH CAUSED SOME DEFORMITY OF THE FILTER AND, THEREFORE, FURTHER ATTEMPTS AT RETRIEVAL WERE ABANDONED. THE PATIENT'S LATER POSTOPERATIVE RECOVERY WAS COMPLICATED BY A RIGHT HEMISPHERIC CEREBROVASCULAR ACCIDENT. THE FILTER REMAINED IN SITU.

    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