BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIDIAN FILTER SYSTEM - FEMORAL

    MDR report key: 6194238 · Received December 21, 2016

    Report

    Report Number
    2020394-2016-01189
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    September 12, 2014
    Report Date
    February 21, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K112497
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. APPROXIMATELY ONE YEAR SEVEN MONTHS POST FILTER DEPLOYMENT, THE PATIENT WAS DOCUMENTED TO HAVE EXPERIENCED PULMONARY EMBOLISM. AROUND TWO MONTHS LATER, THE PATIENT RETURNED TO THE HOSPITAL FOR NEW BLOOD CLOTS IN THE LEFT LEG AND IVC. AROUND ONE MONTH LATER, AN INFERIOR VENA CAVOGRAM SHOWED OCCLUSION AT THE LEVEL OF THE FILTER. AROUND FOUR YEARS LATER, A LUNG VENTILATION PERFUSION STUDY WAS PERFORMED WHICH SHOWED LOW PROBABILITY FOR PULMONARY EMBOLISM. THEREFORE THE INVESTIGATION IS CONFIRMED FOR OCCLUSION OF INFERIOR VENA CAVA. ADDITIONALLY, IT CAN BE CONFIRMED THAT THE PATIENT EXPERIENCED PE POST DEPLOYMENT. HOWEVER, THE RELATIONSHIP TO THE FILTER IS UNKNOWN. 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. H11:SECTION A THROUGH F - 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 · 0

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT A VENA CAVA FILTER WAS PLACED IN CONJUNCTION WITH TRAUMA SITUATION/MOTOR VEHICLE ACCIDENT. APPROXIMATELY ONE YEAR SEVEN MONTHS POST VENA CAVA FILTER DEPLOYMENT FOR HISTORY OF DEEP VEIN THROMBOSIS WITH CONTRAINDICATION TO ANTICOAGULATION SECONDARY TO POSSIBLE UPCOMING SURGICAL PROCEDURE, THE PATIENT EXPERIENCED PULMONARY EMBOLISM AND WAS ADMITTED OVERNIGHT. APPROXIMATELY ONE YEAR NINE MONTHS POST FILTER DEPLOYMENT, THE PATIENT RETURNED TO THE HOSPITAL FOR NEW BLOOD CLOTS IN THE LEFT LEG AND INFERIOR VENA CAVA. TWO ATTEMPTS TO PERFORM THROMBOLYSIS WERE UNSUCCESSFUL DUE TO THE PATIENT EXPERIENCING PAIN AND DISLODGING THE CATHETER. THE PATIENT WAS PLACED ON ANTICOAGULANTS WHICH IMPROVED THE LEG SWELLING. AT SOME TIME POST FILTER DEPLOYMENT, IT WAS ALLEGED THAT FILTER CLOGGED. THE DEVICE HAS NOT BEEN REMOVED AND THERE WERE NO REPORTED ATTEMPTS MADE TO RETRIEVE THE FILTER. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    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 EVENT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. 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 SEVERE DISEASE IN THE CERVICAL SPINE, A HISTORY OF DEEP VENOUS THROMBOSIS AND CONTRAINDICATION TO ANTICOAGULATION SECONDARY TO POSSIBLE UPCOMING SURGERY, PRESENTED FOR PLACEMENT OF A VENA CAVA FILTER. THE LEFT GROIN WAS PREPPED AND DRAPED IN STERILE FASHION. ULTRASOUND GUIDANCE WAS USED TO GAIN ACCESS INTO THE LEFT COMMON FEMORAL VEIN. UTILIZING MODIFIED SELDINGER TECHNIQUE, AN INTRODUCER SHEATH SYSTEM WAS ADVANCED TO THE CAUDAL IVC. INFERIOR VENACAVOGRAM WAS PERFORMED TO DOCUMENT PATENCY OF THE IVC AND LOCATION OF THE RENAL VEINS. SUBSEQUENTLY, THE SHEATH WAS INTRODUCED TO THE APPROPRIATE MID INFERIOR VENA CAVA LOCATION. USING STANDARD TECHNIQUE AN IVC FILTER WAS SUCCESSFULLY DEPLOYED IN THE IVC BELOW THE LEVEL OF THE RENAL VEINS. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLAINT OR COMPLICATION. HEMOSTASIS WAS ESTABLISHED IN THE RIGHT GROIN. THE PATIENT WAS DISCHARGED IN STABLE AND SATISFACTORY CONDITION. APPROXIMATELY ONE YEAR SEVEN MONTHS POST FILTER DEPLOYMENT, THE PATIENT WAS DOCUMENTED TO HAVE EXPERIENCED PULMONARY EMBOLISM AND WAS ADMITTED OVERNIGHT. APPROXIMATELY ONE YEAR NINE MONTHS POST FILTER DEPLOYMENT, THE PATIENT RETURNED TO THE HOSPITAL FOR NEW BLOOD CLOTS IN THE LEFT LEG AND IVC. TWO ATTEMPTS TO PERFORM THROMBOLYSIS WERE UNSUCCESSFUL DUE TO THE PATIENT EXPERIENCING PAIN AND DISLODGING THE CATHETER. THE PATIENT WAS PLACED ON ANTICOAGULATION THERAPY AND THE SWELLING WAS IMPROVING. THE PATIENT WAS DISCHARGED THREE DAYS POST ADMISSION IN STABLE CONDITION. IMAGE/PHOTO REVIEW: NO IMAGES OR PHOTOS 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 SUCCESSFULLY DEPLOYED BELOW THE RENAL VEINS. ONE YEAR AND SEVEN MONTHS POST FILTER DEPLOYMENT, THE PATIENT WAS DOCUMENTS TO HAVE EXPERIENCED PE. ONE YEAR AND NINE MONTHS POST FILTER DEPLOYMENT, THE PATIENT HAD TWO ATTEMPTS AT THROMBOLYSIS HOWEVER IT WAS NOT IDENTIFIED IF THE CLOT WAS OCCLUDING THE FILTER. BASED ON THE MEDICAL RECORDS, THE INVESTIGATION IS INCONCLUSIVE FOR OCCLUSION WITHIN THE DEVICE. HOWEVER, PE AFTER IMPLANTATION CAN BE CONFIRMED BUT THE LOCATION TO WHICH IT ORIGINATED AND THE RELATIONSHIP TO THE FILTER IS UNKNOWN. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: POTENTIAL COMPLICATIONS: - CAVAL THROMBOSIS/OCCLUSION 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 PROVIDED. THE PATIENT STATUS AT THIS TIME IS UNKNOWN. NEW INFORMATION RECEIVED: MEDICAL RECORDS WERE RECEIVED AND REVIEWED. APPROXIMATELY ONE YEAR SEVEN MONTHS POST VENA CAVA FILTER DEPLOYMENT FOR HISTORY OF DVT WITH CONTRAINDICATION TO ANTICOAGULATION SECONDARY TO POSSIBLE UPCOMING SURGICAL PROCEDURE, THE PATIENT EXPERIENCED PULMONARY EMBOLISM AND WAS ADMITTED OVERNIGHT. APPROXIMATELY ONE YEAR NINE MONTHS POST FILTER DEPLOYMENT, THE PATIENT RETURNED TO THE HOSPITAL FOR NEW BLOOD CLOTS IN THE LEFT LEG AND IVC. TWO ATTEMPTS TO PERFORM THROMBOLYSIS WERE UNSUCCESSFUL DUE TO THE PATIENT EXPERIENCING PAIN AND DISLODGING THE CATHETER. THE PATIENT WAS PLACED ON ANTICOAGULANTS WHICH IMPROVED THE LEG SWELLING. THE PATIENT WAS DISCHARGED THREE DAYS LATER IN STABLE CONDITION. NO ADDITIONAL MEDICAL RECORDS WERE RECEIVED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842680 MERIDIAN FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFWD2817

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Life Threatening| H LOVENOX| LOVENOX| LOVENOX