BEUDAMED
    FDA Adverse Event Death Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 6723687 · Received July 18, 2017

    Report

    Report Number
    2020394-2017-00815
    Event Type
    Death
    Date Received
    July 18, 2017
    Report Date
    July 18, 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
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. 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: THE PATIENT WITH HISTORY OF DEEP VENOUS THROMBOSIS, PULMONARY EMBOLUS, HEMATURIA AND GI BLEED WHILE ON ANTICOAGULATION WAS SCHEDULED FOR INFERIOR VENA CAVA (IVC) FILTER PLACEMENT. THE LEFT COMMON FEMORAL VEIN WAS ACCESSED AND A J WIRE WAS INSERTED UP INTO THE IVC. A SHEATH WAS INSERTED OVER THE WIRE AND AN INFERIOR VENA CAVOGRAM WAS PERFORMED IDENTIFYING THE RENAL VEINS AND DEMONSTRATING PATENCY OF THE VENA CAVA. A RETRIEVABLE FILTER WAS THEN INSERTED THROUGH THE SHEATH AND DEPLOYED IN AN INFRARENAL LOCATION. COMPLETION VENOGRAM DEMONSTRATED EXCELLENT RESULT WITH GOOD WALL APPOSITION. THE SHEATH WAS REMOVED AND HEMOSTASIS WAS ACHIEVED. DRESSINGS WERE APPLIED AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. IMAGE/PHOTO REVIEW: AS MEDICAL IMAGES WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: 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 THAT 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. NEW INFORMATION RECEIVED: MEDICAL RECORDS WERE RECEIVED AND REVIEWED. THE PATIENT WITH HISTORY OF DEEP VENOUS THROMBOSIS, PULMONARY EMBOLUS AND CONTRADICTION TO ANTICOAGULATION WAS SCHEDULED FOR VENA CAVA PLACEMENT. THE LEFT COMMON FEMORAL VEIN WAS ACCESSED AND AN INFERIOR VENA CAVOGRAM WAS PERFORMED WHICH IDENTIFIED THE RENAL VEINS AND DEMONSTRATED PATENCY OF THE VENA CAVA. THE FILTER WAS THEN DEPLOYED IN AN INFRARENAL LOCATION WITH GOOD WALL APPOSITION. HEMOSTASIS WAS ACHIEVED AND THE PATIENT WAS TRANSFERRED IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED IN THE MEDICAL RECORDS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503679 DENALI FEMORAL SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. DL900F UNKNOWN 00801741040801

    Patients

    Seq Age Sex Outcome Treatment
    1 Death