BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERIDIAN FILTER SYSTEM - JUGULAR

    MDR report key: 7039725 · Received November 16, 2017

    Report

    Report Number
    2020394-2017-01576
    Event Type
    Death
    Date Received
    November 16, 2017
    Date of Event
    July 10, 2014
    Report Date
    August 21, 2020
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K102511
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. APPROXIMATELY AFTER SEVEN MONTHS POST FILTER DEPLOYMENT, FILTER RETRIEVAL WAS SCHEDULED. MULTIPLE TIMES WERE MADE AT PASSING A GLIDE WIRE PASSED THIS FILTER WERE UNSUCCESSFULLY. GIVEN THE CHRONIC-APPEARING OCCLUSION OF INFERIOR VENA CAVA, FILTER COULD NOT BE RETRIEVED. APPROXIMATELY TWO YEARS LATER, COMPUTED TOMOGRAPHY REVEALED THE INFERIOR VENA CAVA HAS A FILTER AND WAS RATHER SMALL BELOW THE FILTER. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR RETRIEVAL DIFFICULTIES. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. PRODUCT CATALOG NO), (RESULTS AND CONCLUSION. SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE DEVICE WAS UNABLE TO BE RETRIEVED. THE DEVICE HAS NOT BEEN REMOVED AFTER AN ATTEMPTED BUT UNSUCCESSFUL PERCUTANEOUS REMOVAL PROCEDURE. THE PATIENT REPORTEDLY EXPIRED.

    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 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. DETACHMENT OF COMPONENTS, 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.

    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 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: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. (OUTCOMES ATTRIBUTED TO ADV EV).

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOME TIME POST VENA CAVA 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOME TIME POST VENA CAVA 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. NEW INFORMATION RECEIVED: IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN A PATIENT AFTER BEING DIAGNOSED WITH DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT THE DEVICE WAS UNABLE TO BE RETRIEVED. THE DEVICE HAS NOT BEEN REMOVED AFTER AN ATTEMPTED BUT UNSUCCESSFUL PERCUTANEOUS REMOVAL PROCEDURE. THE PATIENT EXPERIENCED PAIN AND SWELLING. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817944 MERIDIAN FILTER SYSTEM - JUGULAR VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| O LOVENOX, HEPARIN| LOVENOX, HEPARIN| LOVENOX, HEPARIN