BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRAPEASE PERMANENT VENA CAVA FILTER

    MDR report key: 3970546 · Received July 31, 2014

    Report

    Report Number
    9616099-2014-00506
    Event Type
    Death
    Date Received
    July 31, 2014
    Date of Event
    November 7, 2013
    Report Date
    September 29, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE IT IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: IT WAS REPORTED BY THE AFFILIATE THAT A PATIENT IMPLANTED WITH TRAPEASE WAS FOUND WITH IVC PERFORATION. THE PATIENT PASSED AWAY THE NEXT DAY. THE INDICATION FOR IVC FILTER INSERTION FOR THE PATIENT IS FOR DVT-DEEP VEIN THROMBOSIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE IT WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15870138 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. INJURY TO THE INFERIOR VENA CAVA (SUCH AS VESSEL PERFORATION) DURING FILTER IMPLANTATION IS A POTENTIAL COMPLICATION AND IS LISTED IN THE IFU AS SUCH. IT IS UNKNOWN IF THE VESSEL WALL INJURY OCCURRED DURING THE PROCEDURE OR ANY TIME AFTERWARDS; HOWEVER, APPROPRIATE DEVICE SELECTION BASED ON SIZE OF VENA CAVA, HANDLING TECHNIQUES (PROPER DEPLOYMENT), AND/OR VESSEL CHARACTERISTICS OF THE INFERIOR VENA CAVA MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. IT WAS REPORTED THAT THE PATIENT PASSED AWAY THE DAY AFTER THE PERFORATION OCCURRED. IN THIS CASE, THE CAUSE OF DEATH CURRENTLY IS UNKNOWN; HOWEVER, IT¿S LIKELY RELATED TO THE INFERIOR VENA CAVA INJURY REPORTED. DEPENDING OF THE DEGREE OF INJURY, A PERFORATION IN THE INFERIOR VENA COULD BE FLOW LIMITING AND LEAD TO INTERNAL HEMORRHAGING, WHICH COULD RESULT IN DEATH. HOWEVER, BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, A CONCLUSION CANNOT BE DRAWN ON POSSIBLE CONTRIBUTING FACTORS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE DHR AND THE INFORMATION PROVIDED, THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED: THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINS OF SHORTNESS OF BREATH AND LEFT LOWER LIMB SWELLING. THE PATIENT WAS DIAGNOSED WITH A PULMONARY EMBOLISM (PE) ON CT PULMONARY ANGIOGRAPHY DATED (B)(6) 2013. A DOPPLER ULTRASOUND EXAMINATION OF THE LOWER LIMBS DONE ON THE SAME DAY ALSO CONFIRMED EXTENSIVE LEFT LOWER LIMB DEEP VEIN THROMBOSIS. THERE WAS SEVERE PULMONARY EMBOLISM WITH LARGE THROMBI SEEN IN BOTH MAIN PULMONARY ARTERIES. EXTENSIVE LEFT LOWER LIMB DVT EXTENDING CRANIALLY UP TO THE LEFT COMMON ILIAC VEIN WAS SEEN. THE PATIENT WAS CONTRAINDICATED FOR ANTICOAGULATION. THE PATIENT WAS INITIALLY GIVEN CLEXANE AND WARFARIN. HOWEVER, THERE WAS DROP IN HEMOGLOBIN FOLLOWING INITIATION OF THE ANTICOAGULATION. ENDOSCOPY PERFORMED AS PART OF WORK UP FOR ANEMIA REVEALED ASCENDING COLON TUMOR. IN VIEW OF HIGH RISK FOR GI BLEEDING, DECISION WAS MADE TO STOP ANTICOAGULATION. A RECURRENT PE WAS NOT ASSESSED. DUE TO THE PATIENT¿S CONDITION, A TRAPEASE FILTER PLACEMENT WAS INDICATED. THERE WERE NO DAMAGES OR ANOMALIES NOTED TO THE FILTER PRIOR TO INSERTION. THE IVC DIAMETER MEASURED ON CAVOGRAPHY WAS 1.8 CM. THE FILTER WAS DEPLOYED IN THE INFRARENAL INFERIOR VENA CAVA ( IVC). NO THROMBUS WAS PRESENT IN THE IVC. THERE WAS NO DIFFICULTY EXPERIENCED AS THE DEVICE WAS BEING INSERTED INTO THE PATIENT. DURING INITIAL PLACEMENT OF THE FILTER, THE OPERATOR DID NOT ENCOUNTER ANY DIFFICULTIES. THE FILTER FULLY EXPANDED WITH GOOD WALL APPOSITION. IT WAS CONFIRMED THAT THE FILTER WAS IN THE CORRECT POSITION AND WAS NOT TILTED ON POST PROCEDURE CAVOGRAM AS WELL AS THE FOLLOW UP KUB RADIOGRAPH. THE DAY AFTER THE PROCEDURE, THE PATIENT DIED. AN IVC PERFORATION WAS FOUND ON THE AUTOPSY. THE EXACT TIMING OF THE PERFORATION IS NOT KNOWN. HOWEVER, THE PERFORATION DID NOT OCCUR DURING POSITIONING OF THE SHEATH, MEASUREMENT OF THE IVC, OR DURING IMPLANTATION OF THE TRAPEASE FILTER. IT IS UNSURE IF THE PERFORATION OCCURRED AFTER IVC FILTER IMPLANTATION. IT WAS REPORTED THAT THE PERFORATION WAS NOT DUE TO THE TRAPEASE FILTER OR ANOTHER DEVICE. THE AUTOPSY REPORT CONCLUDED 5 MM PERFORATION IN THE POSTERIOR IVC WALL AS CAUSE OF THE DEATH. HOWEVER, THE PHYSICIAN DOES NOT BELIEVE THE IVC PERFORATION WAS THE CAUSE OF THE PATIENT¿S DEATH. THE FOLLOW UP RADIOGRAPH AND THE CT ABDOMEN AND PELVIS DEMONSTRATED THE FILTER TO BE SATISFACTORILY PLACED AT TIME OF DEATH. THERE WERE NO ANOMALIES OR PROBLEMS NOTED TO THE FILTER. COMPLAINT CONCLUSION: IT WAS REPORTED BY THE AFFILIATE THAT A PATIENT IMPLANTED WITH TRAPEASE WAS FOUND WITH IVC PERFORATION. THE PATIENT PASSED AWAY THE NEXT DAY. THE INDICATION FOR IVC FILTER INSERTION FOR THE PATIENT IS FOR DVT-DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINS OF SHORTNESS OF BREATH AND LEFT LOWER LIMB SWELLING. THE PATIENT WAS DIAGNOSED WITH A PULMONARY EMBOLISM (PE) ON CT PULMONARY ANGIOGRAPHY DATED (B)(6) 2013. A DOPPLER ULTRASOUND EXAMINATION OF THE LOWER LIMBS DONE ON THE SAME DAY ALSO CONFIRMED EXTENSIVE LEFT LOWER LIMB DEEP VEIN THROMBOSIS. THERE WAS SEVERE PULMONARY EMBOLISM WITH LARGE THROMBI SEEN IN BOTH MAIN PULMONARY ARTERIES. EXTENSIVE LEFT LOWER LIMB DVT EXTENDING CRANIALLY UP TO THE LEFT COMMON ILIAC VEIN WAS SEEN. THE PATIENT WAS CONTRAINDICATED FOR ANTICOAGULATION. THE PATIENT WAS INITIALLY GIVEN CLEXANE AND WARFARIN. HOWEVER, THERE WAS DROP IN HEMOGLOBIN FOLLOWING INITIATION OF THE ANTICOAGULATION. ENDOSCOPY PERFORMED AS PART OF WORK UP FOR ANEMIA REVEALED ASCENDING COLON TUMOR. IN VIEW OF HIGH RISK FOR GI BLEEDING, DECISION WAS MADE TO STOP ANTICOAGULATION. A RECURRENT PE WAS NOT ASSESSED. DUE TO THE PATIENT¿S CONDITION, A TRAPEASE FILTER PLACEMENT WAS INDICATED. THERE WERE NO DAMAGES OR ANOMALIES NOTED TO THE FILTER PRIOR TO INSERTION. THE IVC DIAMETER MEASURED ON CAVOGRAPHY WAS 1.8 CM. THE FILTER WAS DEPLOYED IN THE INFRARENAL INFERIOR VENA CAVA ( IVC). NO THROMBUS WAS PRESENT IN THE IVC. THERE WAS NO DIFFICULTY EXPERIENCED AS THE DEVICE WAS BEING INSERTED INTO THE PATIENT. DURING INITIAL PLACEMENT OF THE FILTER, THE OPERATOR DID NOT ENCOUNTER ANY DIFFICULTIES. THE FILTER FULLY EXPANDED WITH GOOD WALL APPOSITION. IT WAS CONFIRMED THAT THE FILTER WAS IN THE CORRECT POSITION AND WAS NOT TILTED ON POST PROCEDURE CAVOGRAM AS WELL AS THE FOLLOW UP KUB RADIOGRAPH. THE DAY AFTER THE PROCEDURE, THE PATIENT DIED. AN IVC PERFORATION WAS FOUND ON THE AUTOPSY. THE EXACT TIMING OF THE PERFORATION IS NOT KNOWN. HOWEVER, THE PERFORATION DID NOT OCCUR DURING POSITIONING OF THE SHEATH, MEASUREMENT OF THE IVC, OR DURING IMPLANTATION OF THE TRAPEASE FILTER. IT IS UNSURE IF THE PERFORATION OCCURRED AFTER IVC FILTER IMPLANTATION. IT WAS REPORTED THAT THE PERFORATION WAS NOT DUE TO THE TRAPEASE FILTER OR ANOTHER DEVICE. THE AUTOPSY REPORT CONCLUDED 5 MM PERFORATION IN THE POSTERIOR IVC WALL AS CAUSE OF THE DEATH. HOWEVER, THE PHYSICIAN DOES NOT BELIEVE THE IVC PERFORATION WAS THE CAUSE OF THE PATIENT¿S DEATH. THE FOLLOW UP RADIOGRAPH AND THE CT ABDOMEN AND PELVIS DEMONSTRATED THE FILTER TO BE SATISFACTORILY PLACED AT TIME OF DEATH. THERE WERE NO ANOMALIES OR PROBLEMS NOTED TO THE FILTER. THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE IT WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15870138 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. INJURY TO THE INFERIOR VENA CAVA (SUCH AS VESSEL PERFORATION) DURING FILTER IMPLANTATION IS A POTENTIAL COMPLICATION AND IS LISTED IN THE IFU AS SUCH. IT IS UNKNOWN IF THE VESSEL WALL INJURY OCCURRED DURING THE PROCEDURE OR ANY TIME AFTERWARDS; HOWEVER, APPROPRIATE DEVICE SELECTION BASED ON SIZE OF VENA CAVA, HANDLING TECHNIQUES (PROPER DEPLOYMENT), AND/OR VESSEL CHARACTERISTICS OF THE INFERIOR VENA CAVA MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IT WAS REPORTED THAT THE PATIENT PASSED AWAY THE DAY AFTER THE FILTER WAS IMPLANTED. IN THIS CASE, THE CAUSE OF DEATH CURRENTLY IS REPORTED TO BE DUE TO THE PERFORATION ACCORDING TO THE AUTOPSY REPORT; HOWEVER, THE PHYSICIAN DOES NOT AGREE. DEPENDING ON THE DEGREE OF INJURY, A PERFORATION IN THE INFERIOR VENA COULD BE FLOW LIMITING AND LEAD TO INTERNAL HEMORRHAGING, WHICH COULD RESULT IN DEATH. HOWEVER, THE PATIENT HAD A SERIOUS MEDICAL CONDITION OF THROMBI IN THE PULMONARY ARTERIES WITH CONTRAINDICATION TO ANTICOAGULANTS, WHICH COULD ALSO RESULT IN DEATH DEPENDING ON THE SEVERITY. HOWEVER, BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, A CONCLUSION CANNOT BE DRAWN ON POSSIBLE CONTRIBUTING FACTORS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE DHR, THE REPORTED EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT A PATIENT IMPLANTED WITH TRAPEASE WAS FOUND WITH INFERIOR VENA CAVA (IVC) PERFORATION. THE PATIENT PASSED AWAY THE NEXT DAY. THE INDICATION FOR IVC FILTER INSERTION FOR THE PATIENT IS FOR DVT-DEEP VEIN THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447698 TRAPEASE PERMANENT VENA CAVA FILTER THROMBECTOMY SYSTEMS (DQO) DTK CORDIS DE MEXICO NA 15870138

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| L