BEUDAMED
    FDA Adverse Event Death Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 4905280 · Received July 6, 2015

    Report

    Report Number
    2020394-2015-01009
    Event Type
    Death
    Date Received
    July 6, 2015
    Date of Event
    May 13, 2015
    Report Date
    February 14, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K130366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSES FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS FAILURE MODE. THE DEVICE WAS NOT RETURNED. IMAGES WERE NOT PROVIDED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE FOR FILTER MIGRATION. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    VISUAL/MICROSCOPIC INSPECTION: AS THE DEVICE WAS NOT RETURNED, AN INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: AS THE DEVICE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: NO MEDICAL RECORDS HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. IMAGE/PHOTO REVIEW: MEDICAL IMAGES RECEIVED AND REVIEWED. BASED ON THE IMAGES PROVIDED, A DENALI FILTER IS IN AN UPRIGHT POSITION IN THE IVC, SIX ARMS AND SIX LEGS CAN BE COUNTED; HOWEVER, THE LOCATION OF THE FILTER DEPLOYMENT CANNOT BE DETERMINED BASED ON THE MAGNIFIED IMAGE OF THE FILTER. BASED ON THE IMAGES PROVIDED, TWO FILTERS ARE IDENTIFIED IN THE IVC; THE INFERIOR FILTER DEPLOYMENT CAN BE CONFIRMED FOR FILTER TILT. BASED ON THE IMAGES PROVIDED, THE SUPERIOR DEPLOYED FILTER CAN BE CONFIRMED IN AN UPRIGHT POSITION. BASED ON THE IMAGES PROVIDED, THE TILTED FILTER CANNOT BE IDENTIFIED DUE TO POOR IMAGE QUALITY. THE LOCATION OF BOTH FILTERS IN THE IVC CANNOT BE DETERMINED DUE TO CONTRIBUTING FACTORS OF POOR IMAGE QUALITY AND A DIGITAL SUBTRACTION ANGIO. BASED ON THE IMAGES PROVIDED, FILTER REMOVAL OF ONE OR BOTH FILTERS CANNOT BE CONFIRMED. BASED ON IMAGES PROVIDED, FILTER MIGRATION CANNOT BE CONFIRMED. CONCLUSION: THE DEVICE WAS NOT RETURNED. THREE IMAGES WERE RETURNED. BASED ON THE IMAGE REVIEW, THE INVESTIGATION IS CONFIRMED FOR FILTER TILT. THE LOCATION OF THE FILTER COULD NOT BE DETERMINED BASED ON THE IMAGES PROVIDED; THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR CEPHALAD MIGRATION. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: THE DENALI FILTER INSTRUCTIONS FOR USE (IFU) PROVIDES GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. 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

    OPERATOR OF DEVICE - OTHER: NA. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENA CAVA FILTER WAS DEPLOYED FOR PROTECTION OF DVT AND PULMONARY EMBOLISM FOR SURGERY. APPROXIMATELY ONE MONTH POST FILTER DEPLOYMENT, A CT SCAN PERFORMED DEMONSTRATED THE FILTER HAD MIGRATED TO THE RIGHT RENAL TAKEOFF. THE CT SCAN DEMONSTRATED DVT EXTENDING FROM BILATERAL LOWER EXTREMITIES TO THE VENA CAVA FILTER PLACEMENT; THROMBUS WAS NOT IDENTIFIED SUPERIOR TO THE VENA CAVA FILTER. A THROMBOLYTIC AGENT (TPA) WAS ADMINISTERED VIA IV DRIP FOR 23 HOURS, AT THAT TIME MECHANICAL THROMBECTOMY WAS PERFORMED TO REMOVE THROMBUS IN THE IVC AND BILATERAL LOWER EXTREMITIES. ONE WEEK LATER THE FILTER WAS RETRIEVED WITHOUT INCIDENT, A NEW FILTER WAS DEPLOYED SUCCESSFULLY, SUPERIOR TO THE RENAL TAKEOFFS. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436676 DENALI FEMORAL SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFZA3552

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death| R