BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN FILTER SYSTEM - FEMORAL

    MDR report key: 6057526 · Received October 26, 2016

    Report

    Report Number
    2020394-2016-01000
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    November 1, 2014
    Report Date
    July 26, 2016
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K112497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT PROVIDED. 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 INDICATION FOR VENA CAVA FILTER PLACEMENT WAS A LEFT LOWER EXTREMITY DVT WITH SUBDURAL HEMATOMA. ACCESS WAS GAINED TO THE LEFT COMMON FEMORAL VEIN USING A MICROPUNCTURE SYSTEM. A VENACAVAGRAM PERFORMED DEMONSTRATED A NORMAL DIAMETER OF THE IVC, THE RENAL VEINS ENTERING THE IVC AT THE L1-L2 LEVEL AND NO CAVAL ANOMALIES OR THROMBUS. THE FILTER WAS DEPLOYED JUST BELOW THE LEVEL OF THE RENAL VEINS. THERE WAS A 20 DEGREE TILT OF THE FILTER WITH THE APEX ABUTTING THE RIGHT LATERAL WALL OF THE IVC. COMPRESSION WAS APPLIED UNTIL HEMOSTASIS WAS ACHIEVED. APPROXIMATELY SIX MONTHS POST FILTER DEPLOYMENT, THE PATIENT WAS SCHEDULED FOR A FILTER RETRIEVAL PROCEDURE. ACCESS WAS GAINED TO THE RIGHT INTERNAL JUGULAR VEIN AND A VENACAVAGRAM DEMONSTRATED THE FILTER TO BE TILTED WITH THE APEX EMBEDDED THROUGH THE IVC WALL AT THE JUNCTION WITH A LARGE GONADAL VEIN. MULTIPLE ATTEMPTS UTILIZING MULTIPLE CATHETERS AND GUIDEWIRE SYSTEMS TO SNARE THE APEX WERE UNSUCCESSFUL. AT ONE POINT, THE FILTER WAS SNARED; HOWEVER, IT COULD NOT BE REMOVED DUE TO EXCESS FORCE NEEDED TO EXTRACT THE APEX FROM THE IVC WALL WITHOUT SIGNIFICANT RISK OF IVC WALL TRAUMA. THE PROCEDURE WAS ABORTED AND IT WAS RECOMMENDED THAT THE FILTER REMAIN IN PLACE DUE TO THE SIGNIFICANT RISK OF REMOVAL. IF THE PATIENT¿S RISK FACTORS WERE TO CHANGE, A REPEAT ATTEMPT AT REMOVAL UTILIZING EITHER LASER OR ALLIGATOR CLIP TECHNIQUE WOULD BE CONSIDERED. IMAGE/PHOTO REVIEW: NO MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. CONCLUSION: THE DEVICE WAS NOT RETURNED. IMAGES WERE NOT PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. A VENA CAVA FILTER WAS DEPLOYED TILTED 20 DEGREES WITH THE APEX OF THE FILTER ABUTTING THE WALL OF THE IVC. SIX MONTHS LATER DURING A RETRIEVAL ATTEMPT, A VENACAVAGRAM IDENTIFIED THE FILTER APEX TO BE PERFORATING THE IVC WALL. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE FILTER, HOWEVER THE FILTER COULD NOT BE REMOVED FROM THE PATIENT. BASED ON THE MEDICAL RECORDS, THE INVESTIGATION IS CONFIRMED FOR FILTER TILT, PERFORATION OF THE FILTER APEX, AND DIFFICULTIES REMOVING THE FILTER. PER THE PROVIDED MEDICAL RECORDS, THE FILTER WAS TILTED. A TILTED FILTER COULD LEAD TO RETRIEVAL DIFFICULTIES. HOWEVER, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS/POTENTIAL COMPLICATIONS: - MOVEMENT, MIGRATION OR TILT OF THE FILTER ARE KNOWN COMPLICATIONS OF VENA CAVA FILTERS. - PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL - FILTER TILT - FILTER MALPOSITION NOTE: IT IS POSSIBLE THAT COMPLICATIONS SUCH AS THOSE DESCRIBED IN THE "WARNINGS", "PRECAUTIONS", OR "POTENTIAL COMPLICATIONS" SECTIONS OF THIS INSTRUCTIONS FOR USE MAY AFFECT THE RECOVERABILITY OF THE DEVICE AND RESULT IN THE CLINICIAN'S DECISION TO HAVE THE DEVICE REMAIN PERMANENTLY IMPLANTED. 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 SUCCESSFULLY, THE REASON FOR THE FILTER DEPLOYMENT WAS NOT PROVIDED. NO ALLEGED DEFICIENCY WITH THE DEVICE WAS REPORTED. NO OTHER INFORMATION REGARDING THIS EVENT WAS RECEIVED. PATIENT STATUS WAS NOT PROVIDED. NEW INFORMATION RECEIVED: MEDICAL RECORDS WERE RECEIVED AND REVIEWED. DURING A VENA CAVA FILTER DEPLOYMENT PROCEDURE, POST DEPLOYMENT IMAGING DEMONSTRATED THE FILTER TO BE TILTED. NO ATTEMPT WAS MADE TO RETRIEVE THE FILTER AND THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE CONCLUSION OF THE PROCEDURE. APPROXIMATELY SIX MONTHS POST FILTER DEPLOYMENT, DURING A FILTER RETRIEVAL PROCEDURE, THE FILTER APEX WAS FOUND TO BE EMBEDDED THROUGH THE IVC WALL. DESPITE MULTIPLE ATTEMPTS WITH MULTIPLE DEVICES, THE FILTER WAS UNABLE TO BE RETRIEVED. THE PATIENT STATUS WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED IN THE MEDICAL RECORDS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708065 MERIDIAN FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR