BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI FILTER SYSTEM

    MDR report key: 7249989 · Received February 7, 2018

    Report

    Report Number
    2020394-2018-00070
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    December 19, 2017
    Report Date
    February 7, 2018
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K130366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. RAMASWAMY, R. S., JUN, E., BEEK, D.V., MANI, N., SALTER, A.,KIM, S.K., & AKINWANDE, O. (2017). DENALI, TULIP, AND OPTION INFERIOR VENA CAVA FILTER RETRIEVAL: A SINGLE CENTER EXPERIENCE. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE, 1-6. DOI: 10.1007/S00270-017-1866-Z. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, ONE IMAGE WAS PROVIDED AND REVIEWED. A FILTER CAN BE IDENTIFIED AS TILTED WITHIN THE PROVIDED IMAGE. HOWEVER, THE IMAGE COULD NOT IDENTIFY IF ANY OF THE FILTER LIMBS WERE PERFORATING THE IVC WALL DUE TO IMAGE TYPE. THE IMAGE DID NOT SHOW ANY RETRIEVAL DEVICE OR RETRIEVAL ATTEMPT. THEREFORE, THE INVESTIGATION CAN BE CONFIRMED FOR A TILTED FILTER. THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED FILTER LIMB PERFORATION AND RETRIEVAL DIFFICULTIES. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS/POTENTIAL COMPLICATIONS: MOVEMENT, MIGRATION OR TILT OF THE FILTER ARE KNOWN COMPLICATIONS OF VENA CAVA FILTERS. PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL. FILTER TILT, FILTER MALPOSITION. NOTE: IT IS POSSIBLE THAT COMPLICATIONS SUCH AS THOSE DESCRIBED IN THE "WARNINGS", "PRECAUTIONS", OR "POTENTIAL COMPLICATIONS" SECTIONS OF THIS INSTRUCTIONS FOR USE MAY AFFECT THE RECOVERABILITY OF THE DEVICE AND RESULT IN THE CLINICIAN'S DECISION TO HAVE THE DEVICE REMAIN PERMANENTLY IMPLANTED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE TITLED "DENALI, TULIP, AND OPTION INFERIOR VENA CAVA FILTER RETRIEVAL: A SINGLE CENTER EXPERIENCE," THAT A FILTER RETRIEVAL PROCEDURE WAS UNSUCCESSFUL DUE TO FILTER TILT AND LIMB PERFORATION OF THE CAVA WALL. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91652 DENALI FILTER SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1