BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI FILTER SYSTEM

    MDR report key: 7165743 · Received January 4, 2018

    Report

    Report Number
    2020394-2018-00003
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    March 3, 2017
    Report Date
    January 26, 2018
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K130366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO HOSPITAL/MEDICAL RECORDS OR MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL NOT BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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.

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED FILTER LIMB DETACHMENT AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE FILTER. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS/POTENTIAL COMPLICATIONS: FILTER FRACTURES ARE A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN SOME REPORTS OF SERIOUS PULMONARY AND CARDIAC COMPLICATIONS WITH VENA CAVA FILTERS REQUIRING THE RETRIEVAL OF THE FRAGMENT UTILIZING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. CITATION: KLINKEN, S., HUMPHRIES, C., & FERGUSON, J. (2017). ESTABLISHMENT OF AN INFERIOR VENA CAVA FILTER DATABASE AND INTERVENTIONAL RADIOLOGY LED FOLLOW-UP - RETRIEVAL RATES AND PATIENTS LOST TO FOLLOW-UP. JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY, 61, 630-635. DOI: 10.1111/1754-9485.12611.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY THAT SOMETIME POST FILTER DEPLOYMENT (DATE NOT PROVIDED) A DETACHED LIMB WAS IDENTIFIED. THERE IS NO INFORMATION PROVIDED IF THE FILTER OR DETACHED LIMB WAS REMOVED. THERE IS NO OTHER PERTINENT PATIENT, DEVICE OR MEDICAL INFORMATION PROVIDED LEADING UP TO OR SURROUNDING THE EVENT. THE CURRENT PATIENT STATUS IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY THAT SOMETIME POST FILTER DEPLOYMENT (DATE NOT PROVIDED) A DETACHED LIMB WAS IDENTIFIED. THERE IS NO INFORMATION PROVIDED IF THE FILTER OR DETACHED LIMB WAS REMOVED. THERE IS NO OTHER PERTINENT PATIENT, DEVICE OR MEDICAL INFORMATION PROVIDED LEADING UP TO OR SURROUNDING THE EVENT. THE CURRENT PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9248 DENALI FILTER SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1