UNKNOWN TRAPEASE VENA CAVA FILTER
Report
- Report Number
- 1016427-2018-02281
- Event Type
- Injury
- Date Received
- November 20, 2018
- Date of Event
- May 24, 2018
- Report Date
- June 7, 2019
- Manufacturer
- CORDIS CASHEL
- Product Code
- DTK
- PMA / PMN Number
- K020316
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, EI
- Reporter Occupation
- OTHER
Narratives
IT WAS REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE INFORMATION PROVIDED INDICATED THAT THE FILTER TILTED, FRACTURED, MIGRATED OTHER THAN TO THE HEART AND PERFORATED OUTSIDE THE INFERIOR VENA CAVA. THE PATIENT ALSO REPORTS EXPERIENCING EMOTIONAL DISTRESS, MENTAL ANGUISH, ANXIETY AND STRESS. ACCORDING TO THE MEDICAL RECORDS THE PATIENT HAD A HISTORY OF RENAL FAILURE, DEEP VEIN THROMBOSIS AND RESPIRATORY INSUFFICIENCY. THE FILTER WAS PLACED VIA THE RIGHT COMMON FEMORAL VEIN AND DEPLOYED CAUDAL TO THE RENAL VEINS, IN GOOD POSITION. THERE WERE NO IMMEDIATE COMPLICATIONS AND WAS STATED TO BE A SUCCESSFUL PLACEMENT. THE INFORMATION PROVIDED INDICATED THAT THE RESULTS OF A COMPUTED TOMOGRAPHY (CT) SCAN, PERFORMED AT AN UNKNOWN TIME, SHOWED THAT THE FILTER IS TILTED, MIGRATED, PERFORATED AND FRACTURED. THERE IS CURRENTLY NO ADDITIONAL INFORMATION AVAILABLE FOR REVIEW. 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. 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. 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 INCLUDES 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. IVC FILTER TILT HAS BEEN ASSOCIATED WITH THE ANATOMY OF THE VESSEL, SPECIFICALLY ASYMMETRY AND TORTUOUSITY. PERFORATION WAS ALSO REPORTED; HOWEVER, A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. IT IS UNKNOWN IF THE TILT CONTRIBUTED TO THE REPORTED PERFORATION. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL AND LONG-TERM COMPLICATIONS RELATED TO IVC FILTERS. WITHOUT IMAGES OR PROCEDURAL FILMS FOR REVIEW, THE REPORTED FILTER TILT, MIGRATION, FRACTURE AND PERFORATION COULD NOT BE CONFIRMED, AND THE EXACT CAUSES COULD NOT BE DETERMINED. ANXIETY DOES NOT REPRESENT A DEVICE MALFUNCTION AND MAY BE RELATED TO UNDERLYING PATIENT SPECIFIC ISSUES. 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.
ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF RENAL FAILURE, DEEP VEIN THROMBOSIS AND RESPIRATORY INSUFFICIENCY. THE FILTER WAS DEPLOYED VIA THE RIGHT COMMON FEMORAL VEIN. IT WAS PLACED IN A GOOD POSITION IN THE INFERIOR VENA CAVA, CAUDAL TO THE RENAL VEINS. THERE WERE NO IMMEDIATE COMPLICATIONS AND WAS STATED TO BE A SUCCESSFUL PLACEMENT. THE RESULTS OF COMPUTED TOMOGRAPHY (CT) SCANS INDICATE THAT THE FILTER IS TILTED, MIGRATED, PERFORATED AND FRACTURED. ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) STATES THAT THE PATIENT EXPERIENCED TILTING OF THE FILTER, MIGRATION OF THE ENTIRE FILTER OTHER THAN TO THE HEART, PERFORATION OF FILTER STRUTS OUTSIDE THE INFERIOR VENA CAVA AND FRACTURE. THE PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY FOUR YEARS AFTER THE INDEX PROCEDURE. THE FORM ALSO STATES THAT THE PATIENT ALSO EXPERIENCED EMOTIONAL DISTRESS, MENTAL ANGUISH, ANXIETY AND STRESS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
CORRECTION TO (PRODUCT CODE).
PLEASE NOTE THAT THE EXACT EVENT DATE IS UNKNOWN AND THAT THE EVENT DATE IS THE COMPLAINT AWARENESS DATE. OCCUPATION: OTHER, SENIOR COUNSEL, LITIGATION. AS REPORTED, 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, MIGRATION, PERFORATION AND FRACTURE. 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, AND PAIN AND SUFFERING, AND OTHER DAMAGES. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE INFERIOR VENA CAVA (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 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 IMAGES OR PROCEDURAL FILMS FOR REVIEW, THE REPORTED FILTER FRACTURE, MIGRATION AND TILT COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. 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. 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 INCLUDES 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. THE TIMING AND MECHANISM OF THE REPORTED FILTER TILT COULD NOT BE DETERMINED. THE BRIEF ALSO REPORTED A PERFORATION OCCURRED; HOWEVER, A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. IT IS UNKNOWN IF THE TILT CONTRIBUTED TO THE REPORTED PERFORATION. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED IT IVC FILTERS. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN AND/OR 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.
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, MIGRATION, PERFORATION AND FRACTURE. 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, AND PAIN AND SUFFERING, AND OTHER DAMAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 929224 | UNKNOWN TRAPEASE VENA CAVA FILTER | FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | CORDIS CASHEL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Life Threatening| O | UNKNOWN CATHETER |