BEUDAMED
    FDA Adverse Event Death Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 7003617 · Received November 6, 2017

    Report

    Report Number
    2020394-2017-01510
    Event Type
    Death
    Date Received
    November 6, 2017
    Report Date
    November 6, 2017
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    UDI-DI
    00801741040801
    PMA / PMN Number
    K130366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORD REVIEW: A PATIENT WITH A HISTORY OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM WAS SCHEDULED FOR PLACEMENT OF A VENA CAVA FILTER PRIOR TO PROSTATECTOMY. THE FEMORAL VEIN WAS CANNULATED AND A VENA CAVAGRAM WAS PERFORMED. THE FILTER WAS DEPLOYED WITHOUT ANY EVENT. THERE WERE NO APPARENT COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE WELL. MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS, AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES WERE NOT PROVIDED FOR REVIEW. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. THERE WAS NO SPECIFIC DEFICIENCY ALLEGED IN THE PROVIDED MEDICAL RECORDS. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE 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: POTENTIAL COMPLICATIONS: POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: ¿ MOVEMENT, MIGRATION OR TILT OF THE FILTER ARE KNOWN COMPLICATIONS OF VENA CAVA FILTERS. MIGRATION OF FILTERS TO THE HEART OR LUNGS HAS BEEN REPORTED. THERE HAVE ALSO BEEN REPORTS OF CAUDAL MIGRATION OF THE FILTER. MIGRATION MAY BE CAUSED BY PLACEMENT IN IVCS WITH DIAMETERS EXCEEDING THE APPROPRIATE LABELED DIMENSIONS SPECIFIED IN THIS IFU. MIGRATION MAY ALSO BE CAUSED BY IMPROPER DEPLOYMENT, DEPLOYMENT INTO CLOTS AND/OR DISLODGEMENT DUE TO LARGE CLOT BURDENS. ¿ 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. ¿ PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL. ¿ ACUTE OR RECURRENT PULMONARY EMBOLISM. THIS HAS BEEN REPORTED DESPITE FILTER USAGE. IT IS NOT KNOWN IF THROMBI PASSED THROUGH THE FILTER, OR ORIGINATED FROM SUPERIOR OR COLLATERAL VESSELS. ¿ DEEP VEIN THROMBOSIS ¿ CAVAL THROMBOSIS/OCCLUSION ¿ EXTRAVASATION OF CONTRAST MATERIAL AT TIME OF VENACAVOGRAM. ¿ AIR EMBOLISM ¿ HEMATOMA OR NERVE INJURY AT THE PUNCTURE SITE OR SUBSEQUENT RETRIEVAL SITE. ¿ HEMORRHAGE ¿ RESTRICTION OF BLOOD FLOW. ¿ OCCLUSION OF SMALL VESSELS. ¿ DISTAL EMBOLIZATION ¿ INFECTION ¿ INTIMAL TEAR ¿ STENOSIS AT IMPLANT SITE. ¿ FAILURE OF FILTER EXPANSION/INCOMPLETE EXPANSION. ¿ INSERTION SITE THROMBOSIS ¿ FILTER MALPOSITION ¿ VESSEL INJURY ¿ ARTERIOVENOUS FISTULA ¿ BACK OR ABDOMINAL PAIN ¿ FILTER TILT ¿ HEMOTHORAX ¿ ORGAN INJURY ¿ PHLEGMASIA CERULEA DOLENS ¿ PNEUMOTHORAX ¿ POSTPHLEBITIC SYNDROME ¿ STROKE ¿ THROMBOPHLEBITIS ¿ VENOUS ULCERATION ¿ BLOOD LOSS ¿ GUIDEWIRE ENTRAPMENT ¿ PAIN ALL OF THE ABOVE COMPLICATIONS MAY BE ASSOCIATED WITH SERIOUS ADVERSE EVENTS SUCH AS MEDICAL INTERVENTION AND/OR DEATH. 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 THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS DEPLOYED FOR HISTORY OF DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. SOME TIME POST FILTER DEPLOYMENT (DATE NOT PROVIDED) IT WAS ALLEGED THAT THE VENA CAVA FILTER WAS UNABLE TO BE RETRIEVED; HOWEVER, THERE WAS NO REPORTED ATTEMPT MADE TO RETRIEVE THE FILTER. SOME TIME POST FILTER DEPLOYMENT (DATE NOT PROVIDED) THE PATIENT EXPIRED. THERE WAS NO SPECIFIC DEVICE MALFUNCTION REPORTED THAT MAY OR MAY NOT HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S DEATH, THE CAUSE OF THE PATIENT¿S DEATH WAS NOT PROVIDED. NO OTHER PERTINENT PATIENT, DEVICE OR MEDICAL INFORMATION WAS PROVIDED LEADING UP TO OR SURROUNDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781857 DENALI FEMORAL SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. DL900F GFYF3836 00801741040801

    Patients

    Seq Age Sex Outcome Treatment
    1 Death