BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE PVCF FEM/JUG 55CM CSI

    MDR report key: 10163346 · Received June 17, 2020

    Report

    Report Number
    1016427-2020-04031
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    September 29, 2016
    Report Date
    July 24, 2020
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE INFERIOR VENA CAVA FILTER. PER THE MEDICAL RECORDS, THE INDICATION WAS SUPRA-MORBID OBESITY WITH VENOUS INSUFFICIENCY AND VARICOSE VEINS. THE FILTER WAS IMPLANTED PRIOR TO GASTRIC BY-PASS SURGERY, WITH THE FILTER WAS PLACED WITH THE TOP BEING 2 CM BELOW THE JUNCTION POINT OF THE LOWER EDGE OF THE LEFT RENAL VEIN. THERE WERE NO REPORTS COMPLICATIONS. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO TILT AND PERFORATION OF ALL FILTER STRUT(S) OUTSIDE OF THE IVC INTO SURROUNDING TISSUE/ORGANS. A CT SCAN, 12 YEARS AFTER IMPLANT, REVEAL THE SUPERIOR END OF THE FILTER AT THE L2-3 INTERSPACE, TILTED ANTERIORLY AT THE SUPERIOR END AND POSTERIORLY AT THE INFERIOR END. ALL THE STRUTS OF THE IVC FILTER PERFORATE THE IVC UP TO 9MM. TWO (2) ANTERIOR STRUTS PERFORATE THE IVC WALL 5MM AND RESIDE WITHIN THE SOFT TISSUES. ONE (1) MEDIAL STRUT PERFORATES THE IVC WALL 5MM AND RESIDES WITHIN THE SOFT TISSUES. ONE (1) POSTERIOR STRUT PERFORATES THE IVC WALL 4MM AND RESIDES WITHIN THE SOFT TISSUES. ONE (1) POSTERIOR STRUT PERFORATES THE IVC WALL 9MM AND CONTACTS THE L3 VERTEBRAL BODY. ONE (1) LATERAL STRUT PERFORATES THE IVC WALL 4MM AND RESIDES WITHIN THE SOFT TISSUES. THERE IS ONE (1) FRACTURED MEDIAL STRUT. PER THE PATIENT PROFILE FORM (PPF), THE PATIENT REPORTS TILT OF THE FILTER, PERFORATION OF FILTER STRUT(S) OUTSIDE OF THE INFERIOR VENA CAVA (IVC), FILTER FRACTURE, PERFORATION OF FILTER STRUT(S) INTO ORGANS AND FILTER FRACTURE (ONE MEDIAL STRUT). THE PATIENT ALSO REPORTS BACK PAIN, STOMACH PAIN, SWELLING IN LEGS, FEAR AND WORRY. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE TRAPEASE VENA CAVA FILTER IS INDICATED FOR USE IN THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PERCUTANEOUS PLACEMENT IN THE VENA CAVA FOR PATIENTS IN WHICH ANTICOAGULANTS ARE CONTRAINDICATED, ANTICOAGULANT THERAPY FOR THROMBOEMBOLIC DISEASE HAS FAILED, EMERGENCY TREATMENT FOLLOWING MASSIVE PULMONARY EMBOLISM WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED OR FOR CHRONIC, RECURRENT PULMONARY EMBOLISM WHERE ANTICOAGULANT THERAPY HAS FAILED, OR IS CONTRAINDICATED. THE PURPOSE OF A VENA CAVA FILTER IS TO CATCH THROMBUS FROM THE LOWER EXTREMITIES AS IT TRAVELS ALONG NORMAL BLOOD FLOW PATTERNS UP TOWARDS THE HEART. THE INSTRUCTIONS FOR USE (IFU) STATES FILTER FRACTURE WITH PERFORATION IS A POTENTIAL COMPLICATION OF VENA CAVA FILTERS. ANATOMIC LOCATIONS THAT CREATE CONCENTRATED STRESS POINTS FROM FILTER DEFORMATION (FOR EXAMPLE, DEPLOYMENT AT APEX OF SCOLIOSIS, OVERLAPPING OF EITHER OF THE RENAL OSTIA, OR PLACEMENT ADJACENT TO A VERTEBRAL OSTEOPHYTE) MAY CONTRIBUTE TO FRACTURE OF A PARTICULAR FILTER STRUT. IT WAS REPORTED THAT THERE WAS PERFORATION OF THE IVC AND ORGANS; HOWEVER, A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED IT IVC FILTERS. WITHOUT PROCEDURAL FILMS FOR REVIEW, THE FILTER TILT REPORTED COULD NOT BE CONFIRMED. ADDITIONALLY, THE TIMING AND MECHANISM OF THE FILTER TILT IS UNKNOWN. IVC FILTER TILT HAS BEEN ASSOCIATED WITH THE ANATOMY OF THE VESSEL, SPECIFICALLY ASYMMETRY AND TORTUOUSNESS. ANXIETY, LEG SWELLING, AND PAIN DO NOT REPRESENT A DEVICE MALFUNCTION AND MAY BE RELATED TO UNDERLYING PATIENT RELATED ISSUES. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION CHARACTERISTICS. WITHOUT PROCEDURAL FILMS OR IMAGES FOR REVIEW THE REPORTED EVENT(S) COULD NOT BE CONFIRMED. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENTS ARE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF SUPRA-MORBID OBESITY WITH VENOUS INSUFFICIENCY AND VARICOSE VEINS. THE FILTER WAS IMPLANTED PRIOR TO PLANED GASTRIC BY-PASS SURGERY AS THE PATIENT WAS HIGH RISK FOR DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. THE FILTER WAS DEPLOYED VIA THE PATIENT'S RIGHT FEMORAL VEIN. IT WAS PLACED WITH THE TOP BEING 2 CM BELOW THE JUNCTION POINT OF THE LOWER EDGE OF THE LEFT RENAL VEIN. THE FILTER HAD GOOD PLACEMENT AND THERE WAS NO MOVEMENT WITH DEEP BREATHING AND VALSALVA MANEUVER. THE PATIENT WAS IN SATISFACTORY CONDITION AFTER THE PROCEDURE. THE RESULTS OF COMPUTED TOMOGRAPHY (CT) SCANS DONE APPROXIMATELY TWELVE YEARS AFTER THE INDEX PROCEDURE INDICATE THAT THE SUPERIOR END OF THE PERMANENT INFERIOR VENA CAVA (IVC) FILTER IS AT THE L2-3 INTERSPACE. THE IVC FILTER IS TILTED ANTERIORLY AT THE SUPERIOR END AND IT DOES NOT CONTACT THE IVC WALL. THE IVC FILTER IS TILTED POSTERIORLY AT THE INFERIOR END AND IT DOES NOT CONTACT THE IVC WALL. ALL THE STRUTS OF THE IVC FILTER PERFORATE THE IVC UP TO 9MM. TWO (2) ANTERIOR STRUTS PERFORATE THE IVC WALL 5MM AND RESIDE WITHIN THE SOFT TISSUES. ONE (1) MEDIAL STRUT PERFORATES THE IVC WALL 5MM AND RESIDES WITHIN THE SOFT TISSUES. ONE (1) POSTERIOR STRUT PERFORATES THE IVC WALL 4MM AND RESIDES WITHIN THE SOFT TISSUES. ONE (1) POSTERIOR STRUT PERFORATES THE IVC WALL 9MM AND CONTACTS THE L3 VERTEBRAL BODY. ONE (1) LATERAL STRUT PERFORATES THE IVC WALL 4MM AND RESIDES WITHIN THE SOFT TISSUES. THERE IS ONE (1) FRACTURED MEDIAL STRUT   ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) STATES THAT THE PATIENT EXPERIENCED TILT OF THE FILTER, PERFORATION OF FILTER STRUT(S) OUTSIDE OF THE INFERIOR VENA CAVA (IVC), FILTER FRACTURE, PERFORATION OF FILTER STRUT(S) INTO ORGANS AND FILTER FRACTURE (ONE MEDIAL STRUT). THE PATIENT CONTINUES TO EXPERIENCE BACK PAIN, STOMACH PAIN, SWELLING IN LEGS, FEAR AND WORRY. THE PATIENT BECAME AWARE OF THE ADDITIONAL EVENTS NINETEEN YEARS AND SIX MONTHS AFTER THE INDEX PROCEDURE.

    Additional Manufacturer Narrative · 1

    REPORTER OCCUPATION: OTHER, SENIOR COUNSEL, LITIGATION. PLEASE NOTE THAT THE EXACT EVENT DATE IS UNKNOWN AND THE EVENT DATE IS THE COMPLAINT AWARENESS DATE. AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE INFERIOR VENA CAVA (IVC) FILTER. THE INDICATION FOR FILTER PLACEMENT IS NOT AVAILABLE. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO TILT OF THE FILTER AND PERFORATION OF ALL FILTER STRUT(S) OUTSIDE OF THE IVC INTO SURROUNDING TISSUE/ORGANS. THE FILTER REMAINS IMPLANTED; THUS, UNAVAILABLE FOR ANALYSIS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE STERILE LOT NUMBER HAS NOT BEEN PROVIDED; THEREFORE, NO DEVICE ANALYSIS NOR DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. THE TRAPEASE VENA CAVA FILTER IS INDICATED FOR USE IN THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PERCUTANEOUS PLACEMENT IN THE VENA CAVA FOR PATIENTS IN WHICH ANTICOAGULANTS ARE CONTRAINDICATED, ANTICOAGULANT THERAPY FOR THROMBOEMBOLIC DISEASE HAS FAILED, EMERGENCY TREATMENT FOLLOWING MASSIVE PULMONARY EMBOLISM WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED OR FOR CHRONIC, RECURRENT PULMONARY EMBOLISM WHERE ANTICOAGULANT THERAPY HAS FAILED, OR IS CONTRAINDICATED. THE PURPOSE OF A VENA CAVA FILTER IS TO CATCH THROMBUS FROM THE LOWER EXTREMITIES AS IT TRAVELS ALONG NORMAL BLOOD FLOW PATTERNS UP TOWARDS THE HEART. WITHOUT PROCEDURAL FILMS FOR REVIEW, THE FILTER TILT REPORTED COULD NOT BE CONFIRMED. ADDITIONALLY, THE TIMING AND MECHANISM OF THE FILTER TILT IS UNKNOWN. IVC FILTER TILT HAS BEEN ASSOCIATED WITH THE ANATOMY OF THE VESSEL, SPECIFICALLY ASYMMETRY AND TORTUOUSNESS. IT WAS REPORTED THAT THERE WAS PERFORATION OF THE IVC; HOWEVER, A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED IT IVC FILTERS. IVC AND ORGAN PERFORATION FROM FILTERS IS RELATIVELY COMMON, AND DIRECTLY RELATED TO HOW LONG THE FILTER HAS BEEN IN PLACE. STUDIES HAVE NOTED A GREATER THAN 80% PERFORATION RATE OVERALL, WITH ALL FILTERS IMAGED AFTER 71 DAYS FROM IMPLANTATION REVEALING SOME LEVEL OF PERFORATION. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION CHARACTERISTICS. WITHOUT PROCEDURAL FILMS OR IMAGES FOR REVIEW THE REPORTED EVENT(S) COULD NOT BE CONFIRMED. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENTS ARE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE REPORT STATES THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO TILT OF THE FILTER AND PERFORATION OF ALL FILTER STRUT(S) OUTSIDE OF THE INFERIOR VENA CAVA (IVC) INTO SURROUNDING TISSUE/ORGANS. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN, SUFFERING, DISTRESS AND OTHER DAMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628726 TRAPEASE PVCF FEM/JUG 55CM CSI FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CORPORATION R0604482

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening UNKNOWN CANNULA| UNKNOWN CATHETER| UNKNOWN DILATOR| UNKNOWN INTRODUCER| UNKNOWN SHEATH