BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRUX VENA CAVA FILTER SYSTEM

    MDR report key: 3778218 · Received April 16, 2014

    Report

    Report Number
    2939520-2014-00029
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 21, 2014
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    K122585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND SERIAL AND LOT # OF THE FILTER SYSTEM WAS NOT AVAILABLE TO BE REPORTED BY THE CLINICAL STAFF. WITHOUT THIS INFORMATION, MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS NOT ABLE TO BE REVIEWED TO CONFIRM THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. IN ADDITION, WITHOUT THIS INFORMATION WE ARE UNABLE TO CONFIRM THAT TO DATE, IF ANY OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS DEVICE'S LOT. SINCE THE PHYSICIAN REPORTED THE VESSEL TO BE OCCLUDED AND THAT INTERVENTION WAS REQUIRED (FILTER RETRIEVAL) THIS REPORT IS BEING SUBMITTED DUE TO AN ABUNDANCE OF CAUTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S SCIENTIFIC AFFAIRS DEPARTMENT COMPLETES THE CLINICAL ASSESSMENT FOR THIS CASE.

    Description of Event or Problem · 1

    CRUX VCF WAS INITIALLY IMPLANTED ON (B)(6) 2014 AND THE OCCLUSION WAS CONFIRMED ON (B)(6) 2014. PATIENT HISTORY INCLUDED TRAUMA WITH INTRACRANIAL BLEEDING. THE PATIENT WAS UNABLE TO BE ANTICOAGULATED DUE TO THE INTRACRANIAL BLEED. AT THE TIME OF THE CRUX VCF INSERTION, THE PATIENT HAD A RIGHT COMMON ILIAC DVT AS WELL AS BILATERAL SOLIEL VEIN DVT. THE PHYSICIAN STATED THAT THE IVC DIAMETER WAS ABOUT 17MM. THE CRUX VCF WAS DEPLOYED VIA THE LEFT FEMORAL VEIN APPROACH. ON (B)(6) 2014, THE PATIENT DEVELOPED DVT IN THE LEFT ILIAC VEIN WHICH CONTINUED INTO THE IVC AND CRUX VCF ALL THE WAY UP TO THE LEVEL OF THE RENAL VEINS. THIS DVT WAS DIAGNOSED VIA VENOUS DUPLEX ULTRASOUND. THE PATIENT THEN HAD A VENOGRAM COMPLETED TO ASSESS THE EXTENT OF THE THROMBOSIS. THE PHYSICIAN STATED THAT THE IVC AND CRUX VCF SHOWED NO FLOW AND WAS OCCLUDED. VOLCANO CLINICAL REP REPORTED THAT THE FILTER WAS REMOVED AND ANOTHER COMPANY FILTER WAS IMPLANTED. THE DATE OF CRUX RETRIEVAL IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233517 CRUX VENA CAVA FILTER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK VOLCANO CORPORATION 7024

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention