BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE PVCF FEM/JUG 55CM CSI

    MDR report key: 8928833 · Received August 25, 2019

    Report

    Report Number
    1016427-2019-03194
    Event Type
    Injury
    Date Received
    August 25, 2019
    Date of Event
    September 11, 2018
    Report Date
    November 15, 2019
    Manufacturer
    CORDIS CASHEL
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE PATIENT IS REPORTED TO HAVE HAD A HISTORY OF MORBID OBESITY, OBSTRUCTIVE SLEEP APNEA, PULMONARY EMBOLISM (PE) AND INFARCTION, LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT), OSTEOARTHRITIS, ORTHOPEDIC ANKLE SURGERY, CHOLECYSTECTOMY, HYSTERECTOMY, HYPERLIPIDEMIA AND LONG-TERM USE OF ANTICOAGULANTS. THE PATIENT IS ALSO REPORTED TO HAVE HAD A RECENT HISTORY OF SHORTNESS OF BREATH, POOR EXERCISE CAPACITY AND A MILDLY DILATED LEFT ATRIUM. THE PATIENT PRESENTED TO THE HOSPITAL WITH SHORTNESS OF BREATH AND LEG SWELLING OVER THE COURSE OF THE PRECEDING WEEK. DIAGNOSTIC TESTING REVEALED LEFT POPLITEAL DVT AND BILATERAL PE. THE FILTER WAS IMPLANTED VIA THE RIGHT FEMORAL VEIN AND PLACED IN AN INFRARENAL POSITION. THE PATIENT IS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL AND WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME A FEW DAYS LATER. IN ADDITION, THE PATIENT REPORTED HAVING BEEN TOLD THAT THE FILTER HAD BEEN IN PLACE FOR OVER TEN YEARS AND WAS UNLIKELY TO BE RETRIEVABLE AT THIS POINT. THE PHYSICIAN RECOMMENDED LEAVING THE FILTER IN PLACE SINCE IT WAS NOT CAUSING THE PATIENT ANY DIFFICULTY AND RETRIEVAL COULD BE COMPLICATED. ATTEMPTS TO RETRIEVE THE FILTER WERE NOT DOCUMENTED. APPROXIMATELY NINE YEARS AND NINE MONTHS AFTER THE IMPLANTATION, AN ABDOMINAL COMPUTERIZED TOMOGRAPHY (CT) REVEALED THAT THE FILTER WAS LOCATED WITH ITS SUPERIOR ASPECT 2.1CM BELOW THE RENAL ARTERY AND VEINS (NO EVIDENCE OF MIGRATION) AND WITHOUT TILT. THERE WAS NO EVIDENCE OF FILTER STRUT FRACTURE. THE CT FURTHER REVEALED THAT THE FILTER STRUTS EXTENDED BEYOND THE WALL OF THE INFERIOR VENA CAVA (IVC) WITHOUT PERFORATION OF ANY ABDOMINAL VISCERAL ORGANS. THE PATIENT FURTHER REPORTED HAVING EXPERIENCED MENTAL ANGUISH ASSOCIATED WITH THE FILTER. 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 PE VIA PERCUTANEOUS PLACEMENT IN THE IVC FOR PATIENTS IN WHICH ANTICOAGULANTS ARE CONTRAINDICATED, ANTICOAGULANT THERAPY FOR THROMBOEMBOLIC DISEASE HAS FAILED, EMERGENCY TREATMENT FOLLOWING MASSIVE PE WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED OR FOR CHRONIC, RECURRENT PE 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 IMAGES OR PROCEDURAL FILMS FOR REVIEW, THE REPORTED FILTER IVC PERFORATION COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED TO IVC FILTERS. 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 THE PATIENT¿S PRE-EXISTING CO-MORBIDITIES, PHARMACOLOGICAL ISSUES AND LESION CHARACTERISTICS. THE ANXIETY EXPERIENCED BY THE PATIENT DOES NOT REPRESENT A DEVICE MALFUNCTION. ANXIETY, PART OF THE BODY¿S NATURAL RESPONSE TO STRESS AND CAN CAUSE FEELINGS OF, BUT NOT LIMITED TO, NERVOUSNESS, MENTAL ANGUISH, FEAR, UNEASE AND WORRY. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW, THERE IS NOTHING TO SUGGEST THAT A MALFUNCTION IN 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

    AS REPORTED BY THE LEGAL BRIEF, THE PATIENT WAS IMPLANTED THE TRAPEASE FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO PATIENT, INCLUDING, BUT NOT LIMITED TO: EXTENSION OF THE STRUTS BEYOND THE WALL OF THE IVC. AS A DIRECT AND PROXIMATE RESULT, 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 AND SUFFERING AND OTHER DAMAGES. THE PATIENT IS REPORTED TO HAVE HAD A HISTORY OF MORBID OBESITY, OBSTRUCTIVE SLEEP APNEA, PULMONARY EMBOLISM (PE) INFARCTION, LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT), OSTEOARTHRITIS, ORTHOPEDIC ANKLE SURGERY, CHOLECYSTECTOMY, HYSTERECTOMY, HYPERLIPIDEMIA, ARTHROPATHY AND LONG-TERM USE OF ANTICOAGULANTS. APPROXIMATELY FOUR MONTHS PRIOR TO THE INDEX PROCEDURE, THE PATIENT UNDERWENT A NUCLEAR STRESS TEST FOR SHORTNESS OF BREATH, THAT REVEALED EXERCISE-INDUCED CHEST PAIN AND SHORTNESS OF BREATH, A NON-ISCHEMIC ELECTROCARDIOGRAM AND POOR EXERCISE CAPACITY. ADDITIONALLY, A STRESS TEST REVEALED NORMAL MYOCARDIAL PERFUSION, NO RESTING WALL MOTION ABNORMALITY AND NORMAL RESTING LEFT VENTRICULAR (LV) EJECTION FRACTION. APPROXIMATELY THREE MONTHS PRIOR TO THE INDEX PROCEDURE, RESULTS OF A TRANSTHORACIC ECHOCARDIOGRAM REVEALED A NORMAL-SIZED LV, NORMAL LV SYSTOLIC FUNCTION WITH AN EJECTION FRACTION OF 76% AND A MILDLY DILATED LEFT ATRIUM. A DAY PRIOR TO THE IMPLANTATION, THE PATIENT PRESENTED TO THE HOSPITAL AND WAS ADMITTED FOR SHORTNESS OF BREATH AND LEG SWELLING OVER THE COURSE OF THE PRECEDING WEEK. DIAGNOSTIC TESTING REVEALED LEFT POPLITEAL DEEP VEIN THROMBOSIS (DVT) AND BILATERAL PULMONARY EMBOLISM (PE). PER THE IMPLANT RECORDS THE PATIENT UNDERWENT FILTER IMPLANTATION VIA THE RIGHT FEMORAL VEIN AND PLACED IN AN INFRARENAL POSITION. THE TRAPEASE FILTER WAS ADVANCED AND DEPLOYED INTO THE INFERIOR VENA CAVA BELOW THE RENAL VEINS. THE PATIENT IS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL AND WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME FOUR DAYS LATER. APPROXIMATELY NINE DAYS AFTER THE FILTER WAS IMPLANTED, THE PATIENT PRESENTED TO THE HOSPITAL WITH LEFT LOWER BACK PAIN AND NUMBNESS. A LUMBAR COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED GRADE 1 SPONDYLOLISTHESIS WITH BILATERAL PARS DEFECT AT L5-S1 WITH BILATERAL SEVERE NEUROFORAMINAL STENOSIS. FIVE DAYS AFTER THE PREVIOUS VISIT, THE PATIENT PRESENTED WITH RIGHT KNEE PAIN. THE PATIENT FURTHER REPORTED ABDOMINAL PAIN WHICH WAS ATTRIBUTED TO DIVERTICULITIS WITH OCCASIONAL NAUSEA. THE PATIENT REPORTED HAVING HAD A COLONOSCOPY THAT REVEALED EVIDENCE OF HEMORRHOIDS. THE PATIENT WAS ALSO NOTED TO BE ANEMIC AND HAD AN ENLARGED LIVER AT THE TIME OF EXAMINATION. APPROXIMATELY NINE YEARS POST IMPLANTATION, A PHYSICAL EXAMINATION OF THE PATIENT REPORTED THAT THE FILTER HAD BEEN IN PLACE FOR OVER TEN YEARS AND WAS UNLIKELY TO BE RETRIEVABLE AT THIS POINT. THE PHYSICIAN RECOMMENDED LEAVING THE FILTER IN PLACE SINCE IT WAS NOT CAUSING THE PATIENT ANY DIFFICULTY AND RETRIEVAL COULD BE COMPLICATED. THE PATIENT UNDERWENT ULTRASOUND-GUIDED BILATERAL KNEE JOINT INJECTIONS OF PREDNISONE. AN ABDOMINAL COMPUTERIZED TOMOGRAPHY (CT) COMPLETED APPROXIMATELY NINE YEARS AND NINE MONTHS AFTER THE FILTER WAS IMPLANTED REVEALED THAT THE FILTER WAS LOCATED WITH ITS SUPERIOR ASPECT 2.1CM BELOW THE RENAL ARTERY AND VEINS (NO EVIDENCE OF MIGRATION) AND WITHOUT TILT. THERE WAS NO EVIDENCE OF FILTER STRUT FRACTURE. THE CT FURTHER REVEALED THAT THE FILTER STRUTS EXTENDED BEYOND THE WALL OF THE INFERIOR VENA CAVA (IVC) WITHOUT PERFORATION OF ANY ABDOMINAL VISCERAL ORGANS. ACCORDING TO THE INFORMATION RECEIVED IN THE PATIENT PROFILE FORM (PPF), THE PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY NINE YEARS POST IMPLANTATION. THE PATIENT REPORTS PERFORATION OF FILTER STRUT(S) OUTSIDE THE IVC AND DEVICE UNABLE TO BE RETRIEVED; HOWEVER, THERE HAVE BEEN NO DOCUMENTED ATTEMPTS TO REMOVE THE FILTER. THE PATIENT ALSO EXPERIENCED ANXIETY RELATED TO THE FILTER.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE INDICATION FOR THE FILTER PLACEMENT WAS NOT REPORTED. AT SOME POINT AFTER THE FILTER IMPLANTATION, THE PATIENT BECAME AWARE THAT FILTER STRUTS EXTENDED BEYOND THE WALL OF THE INFERIOR VENA CAVA (IVC). 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 IVC FOR PATIENTS IN WHICH ANTICOAGULANTS ARE CONTRAINDICATED, ANTICOAGULANT THERAPY FOR THROMBOEMBOLIC DISEASE HAS FAILED, EMERGENCY TREATMENT FOLLOWING MASSIVE PE WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED OR FOR CHRONIC, RECURRENT PE 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 IMAGES OR PROCEDURAL FILMS FOR REVIEW, THE REPORTED FILTER IVC PERFORATION COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU) NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED TO IVC FILTERS. 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 THE PATIENT¿S PRE-EXISTING CO-MORBIDITIES, PHARMACOLOGICAL ISSUES AND LESION CHARACTERISTICS. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW, THERE IS NOTHING TO SUGGEST THAT A MALFUNCTION IN 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 · 1

    AS REPORTED BY THE LEGAL BRIEF, THE PATIENT WAS IMPLANTED THE TRAPEASE FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO PATIENT, INCLUDING, BUT NOT LIMITED TO: EXTENSION OF THE STRUTS BEYOND THE WALL OF THE IVC. AS A DIRECT AND PROXIMATE RESULT, 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 AND SUFFERING, & OTHER DAMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722386 TRAPEASE PVCF FEM/JUG 55CM CSI FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CASHEL 466P306X 14120878

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening