TRAPEASE PVCF BRACH 90CM CSI
Report
- Report Number
- 1016427-2019-02965
- Event Type
- Injury
- Date Received
- June 20, 2019
- Date of Event
- March 26, 2020
- Report Date
- July 6, 2020
- Manufacturer
- CORDIS CASHEL
- 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
AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE INFERIOR VENA CAVA (IVC) FILTER. THE INDICATION FOR FILTER PLACEMENT IS NOT AVAILABLE. PER THE MEDICAL RECORDS, THE PATIENT UNDERWENT A VENOGRAM AND THE INFERIOR VENA CAVA (IVC) FILTER WAS DEPLOYED. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES INCLUDING, BUT NOT LIMITED TO MIGRATION OF THE FILTER AND PERFORATION OF THE FILTER STRUTS. PER THE PATIENT PROFILE FORM (PPF), THE PATIENT REPORTS PERFORATION OF FILTER STRUT(S) OUTSIDE THE IVC, MIGRATION OF THE ENTIRE FILTER OTHER THAN TO THE HEART. A CT SCAN OF THE PATIENT¿S TRAPEASE IVC FILTER REPORTED MIGRATION AND PERFORATION OF THE FILTER STRUTS OUTSIDE THE IVC. THE PATIENT ALSO REPORTS EMOTIONAL DISTRESS, MENTAL ANGUISH, ANXIETY AND STRESS. 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. INFERIOR VENA CAVA (IVC) FILTER MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL IVC FILTER IMPLANTS AND IS LISTED IN THE INSTRUCTION FOR USE (IFU) AS SUCH. POSSIBLE CAUSES FOR FILTER MIGRATION INCLUDE MEGA CAVA, WIRE ENTRAPMENT DURING CENTRAL VENOUS CATHETER PLACEMENT, ¿SAIL¿ EFFECT (CRANIAL MIGRATION) OF LARGE CLOT BURDEN WITHIN THE FILTER, MECHANICAL DEVICE FAILURE, AND OPERATOR ERROR. PHYSIOLOGIC CAUSES OF MIGRATION MAY RESULT FROM TEMPORARY DYSMORPHISM OF THE INFERIOR VENA CAVA INCLUDING BENDING, COUGHING OR VALSALVA MANEUVERS RESULTING IN DISLODGMENT OF THE FILTER. SOME STUDIES SUGGEST THAT STRENUOUS PHYSICAL ACTIVITY AND INCREASED INTRA-ABDOMINAL PRESSURE CAN LEAD TO MIGRATION OF IVC FILTERS. 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 PERFORATION FROM REMOVABLE 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. ANXIETY DOES 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.
IT WAS REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE INFORMATION PROVIDED INDICATED THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED MIGRATION OF THE FILTER AND PERFORATION OF THE FILTER STRUTS AND FRACTURE. THE PATIENT REPORTED BECOMING AWARE OF FILTER MIGRATION AND PERFORATION, AS INDICATED BY A COMPUTERIZED TOMOGRAPHY (CT) SCAN, APPROXIMATELY FOUR YEARS POST IMPLANT. THE PATIENT ALSO REPORTED ANXIETY RELATED TO THESE EVENTS. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT BECAME AWARE OF FILTER MIGRATION AND FRACTURE APPROXIMATELY SIX YEARS POST IMPLANT. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD A HISTORY OF DIABETES, MORBID OBESITY, PRIOR DEEP VEIN THROMBOSIS (DVT) AND A LEFT FEMORAL FRACTURE WHICH OCCURRED TWO TO THREE MONTHS PRIOR TO THE INDEX PROCEDURE. THE PATIENT HAD BEEN NON WEIGHTBEARING DUE TO AN ANKLE FUSION SURGERY. ONCE THE PATIENT BEGAN WEIGHTBEARING, THE LEG BECAME SHORT AND VERY PAINFUL. DUE TO AN INCREASED RISK FOR INFECTION, BLOOD CLOT FORMATION, DISLOCATION DUE TO THE CHRONICITY OF THE FRACTURE AND DIABETES, INTERVENTIONAL RADIOLOGY WAS CONSULTED TO PLACE AN IVC FILTER TO PREVENT A PULMONARY EMBOLISM (PE). THE PATIENT UNDERWENT A VENOGRAM AND THE INFERIOR VENA CAVA (IVC) FILTER WAS DEPLOYED. THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT THREE DAYS POST IMPLANT. THERE IS CURRENTLY NO ADDITIONAL INFORMATION AVAILABLE FOR REVIEW. 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 IVC 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 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 PROCEDURAL FILMS OR POST IMPLANT IMAGING AVAILABLE FOR REVIEW, THE REPORTED EVENTS COULD NOT BE CONFIRMED OR FURTHER CLARIFIED. THE INSTRUCTIONS FOR USE (IFU) STATES FILTER FRACTURE 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. THE IFU ALSO NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL AND LONG-TERM COMPLICATIONS RELATED TO IVC FILTERS. IVC FILTER MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL IVC FILTER IMPLANTS AND IS LISTED IN THE IFU AS SUCH. POSSIBLE CAUSES FOR FILTER MIGRATION INCLUDE MEGA CAVA, WIRE ENTRAPMENT DURING CENTRAL VENOUS CATHETER PLACEMENT, ¿SAIL¿ EFFECT (CRANIAL MIGRATION) OF LARGE CLOT BURDEN WITHIN THE FILTER, MECHANICAL DEVICE FAILURE, AND OPERATOR ERROR. PHYSIOLOGIC CAUSES OF MIGRATION MAY RESULT FROM TEMPORARY DYSMORPHISM OF THE INFERIOR VENA CAVA INCLUDING BENDING, COUGHING OR VALSALVA MANEUVERS RESULTING IN DISLODGMENT OF THE FILTER. SOME STUDIES SUGGEST THAT STRENUOUS PHYSICAL ACTIVITY AND INCREASED INTRA-ABDOMINAL PRESSURE CAN LEAD TO MIGRATION OF IVC FILTERS. THERE IS NOTHING IN THE LIMITED INFORMATION AVAILABLE TO SUGGEST 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.
AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES INCLUDING, BUT NOT LIMITED TO: MIGRATION OF THE FILTER AND PERFORATION OF THE FILTER STRUTS. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES. PER THE MEDICAL RECORDS, THE PATIENT UNDERWENT A VENOGRAM AND THE INFERIOR VENA CAVA (IVC) FILTER WAS DEPLOYED. ACCORDING TO THE INFORMATION RECEIVED IN THE PATIENT PROFILE FORM (PPF), THE PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY FOUR YEARS POST IMPLANTATION. THE PATIENT REPORTS PERFORATION OF FILTER STRUT(S) OUTSIDE THE IVC, MIGRATION OF THE ENTIRE FILTER OTHER THAN TO THE HEART. A COMPUTERIZED TOMOGRAPHY (CT) SCAN OF THE PATIENT¿S TRAPEASE IVC FILTER REPORTED MIGRATION AND PERFORATION OF THE FILTER STRUTS OUTSIDE THE IVC. THESE INJURIES HAVE CAUSED EMOTIONAL DISTRESS, MENTAL ANGUISH, ANXIETY AND STRESS.
AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES INCLUDING, BUT NOT LIMITED TO: MIGRATION OF THE FILTER AND PERFORATION OF THE FILTER STRUTS. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES. PER THE MEDICAL RECORDS, THE PATIENT UNDERWENT A VENOGRAM AND THE INFERIOR VENA CAVA (IVC) FILTER WAS DEPLOYED. ACCORDING TO THE INFORMATION RECEIVED IN THE PATIENT PROFILE FORM (PPF), THE PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY FOUR YEARS POST IMPLANTATION. THE PATIENT REPORTS PERFORATION OF FILTER STRUT(S) OUTSIDE THE IVC, MIGRATION OF THE ENTIRE FILTER OTHER THAN TO THE HEART. A COMPUTERIZED TOMOGRAPHY (CT) SCAN OF THE PATIENT¿S TRAPEASE IVC FILTER REPORTED MIGRATION AND PERFORATION OF THE FILTER STRUTS OUTSIDE THE IVC. THESE INJURIES HAVE CAUSED EMOTIONAL DISTRESS, MENTAL ANGUISH, ANXIETY AND STRESS. ACCORDING TO THE UPDATED LEGAL BRIEF PROVIDED, THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO FRACTURE AND MIGRATION. ADDITIONAL MEDICAL RECORDS PROVIDED, REVEALED THAT THE PATIENT HAD A HISTORY OF DIABETES AND MORBID OBESITY AND PRESENTED A LEFT FEMORAL FRACTURE WHICH OCCURRED TWO TO THREE MONTHS PRIOR TO THE INDEX PROCEDURE, BUT THE PATIENT HAD BEEN NON WEIGHTBEARING, USING A WALKER DUE TO AN ANKLE FUSION SURGERY. ONCE THE PATIENT BEGAN WEIGHTBEARING, THE LEG BECAME SHORT AND VERY PAINFUL. THE PATIENT HAD AN INCREASED RISK FOR INFECTION AND BLOOD CLOT FORMATION AND DISLOCATION DUE TO THE CHRONICITY OF THE FRACTURE AND THE DIABETES. INTERVENTIONAL RADIOLOGY WAS CONSULTED TO PLACE AN IVC FILTER TO PREVENT A PULMONARY EMBOLISM (PE), AS THE PATIENT HAD A PRIOR TWO-YEAR HISTORY OF DEEP VEIN THROMBOSIS (DVT). THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT THREE DAYS AFTER THE FILTER WAS IMPLANTED. ACCORDING TO THE INFORMATION RECEIVED IN THE PATIENT PROFILE FORM (PPF), THE PATIENT REPORTS FILTER MIGRATION AND FRACTURE WITH FRACTURED FILTER STRUTS RETAINED WITHIN THE INFERIOR VENA CAVA. THE PATIENT FURTHER EXPERIENCED ANXIETY RELATED TO THE FILTER AND BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY SIX YEARS AFTER THE FILTER IMPLANTATION.
COMPLAINT CONCLUSION: AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE INDICATION FOR THE FILTER PLACEMENT WAS NOT REPORTED. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES INCLUDING, BUT NOT LIMITED TO, FILTER MIGRATION AND PERFORATION OF THE FILTER STRUTS. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES. 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 INFERIOR VENA CAVA (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 MIGRATION AND PERFORATION EVENTS COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. IVC FILTER MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL IVC FILTER IMPLANTS AND IS LISTED IN THE INSTRUCTION FOR USE (IFU) AS SUCH. POSSIBLE CAUSES FOR FILTER MIGRATION INCLUDE MEGA CAVA, WIRE ENTRAPMENT DURING CENTRAL VENOUS CATHETER PLACEMENT, ¿SAIL¿ EFFECT (CRANIAL MIGRATION) OF LARGE CLOT BURDEN WITHIN THE FILTER, MECHANICAL DEVICE FAILURE, AND OPERATOR ERROR. PHYSIOLOGIC CAUSES OF MIGRATION MAY RESULT FROM TEMPORARY DYSMORPHISM OF THE IVC INCLUDING BENDING, COUGHING OR VALSALVA MANEUVERS RESULTING IN DISLODGMENT OF THE FILTER. SOME STUDIES SUGGEST THAT STRENUOUS PHYSICAL ACTIVITY AND INCREASED INTRA-ABDOMINAL PRESSURE CAN LEAD TO MIGRATION OF IVC FILTERS. 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.
AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES INCLUDING, BUT NOT LIMITED TO: MIGRATION OF THE FILTER AND PERFORATION OF THE FILTER STRUTS. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, PATIENT SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510494 | TRAPEASE PVCF BRACH 90CM CSI | FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | CORDIS CASHEL | 466P306X | 15799366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Life Threatening | UNK SHEATH |