UNKNOWN TRAPEASE
Report
- Report Number
- 9616099-2022-05383
- Event Type
- Injury
- Date Received
- March 2, 2022
- Date of Event
- August 24, 2021
- Report Date
- April 27, 2022
- 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
- Health Professional
- N
Narratives
OCCUPATION: OTHER, SENIOR COUNSEL, LITIGATION. PLEASE NOTE THAT THE EXACT EVENT DATE IS UNKNOWN AND THE EVENT DATE IS THE COMPLAINT AWARENESS DATE. 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 FILTER FRACTURE, PERFORATION, MIGRATION AND TILT. THE IMPLANT PROCEDURAL DETAILS, INDICATION FOR FILTER PLACEMENT AND MEDICAL HISTORY HAVE NOT BEEN PROVIDED. THERE IS CURRENTLY NO ADDITIONAL INFORMATION AVAILABLE FOR REVIEW. THE PRODUCT REMAINS IMPLANT AND UNAVAILABLE FOR ANALYSIS, 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 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. IVC FILTER TILT HAS BEEN ASSOCIATED WITH PRACTITIONER TECHNIQUE AND VESSEL ANATOMY, SPECIFICALLY ASYMMETRY AND TORTUOSITY. VESSEL PERFORATION IS A KNOWN ADVERSE EVENT ASSOCIATED WITH IMPLANTING VENA CAVA FILTERS AND IS LISTED AS SUCH IN THE INSTRUCTIONS FOR USE (IFU) AND NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL AND LONG-TERM COMPLICATIONS RELATED TO IVC FILTERS. THE IFU ALSO STATES THAT 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. 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. WITHOUT POST IMPLANT IMAGE REPORTS THE REPORTED EVENTS COULD NOT BE CONFIRMED OR FURTHER CLARIFIED. 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 REPORT FOR THIS PRODUCT.
AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED, THE FOLLOWING SECTIONS HAVE BEEN 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 FILTER FRACTURE, PERFORATION, MIGRATION AND TILT. THE PATIENT REPORTED BECOMING AWARE OF FRACTURE, INFERIOR VENA CAVA (IVC) PERFORATION, ORGAN PERFORATION, MIGRATION AND FILTER TILT, APPROXIMATELY FIFTEEN YEARS AND EIGHT MONTHS POST IMPLANT. THE FORM NOTED THAT THE FRACTURED STRUTS WERE RETAINED IN THE IVC AND LEFT RENAL VEIN. THE ALSO REPORTED EXPERIENCING LEFT SIDE PAIN RELATED TO THE FILTER. ACCORDING TO THE INTERVENTIONAL RADIOLOGY REPORT THE INDICATION FOR THE FILTER IMPLANT WAS NECROTIZING FASCIITIS, PULMONARY EMBOLISM AND DEEP VEIN THROMBOSIS. THE FILTER WAS PLACED VIA THE RIGHT INTERNAL JUGULAR VEIN AND WAS DEPLOYED INTO THE INFERIOR VENA CAVA BELOW THE LEVEL OF THE RENAL VEINS UNDER FLUOROSCOPIC OBSERVATION. THE PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO COMPLICATIONS. THE PRODUCT REMAINS IMPLANT AND UNAVAILABLE FOR ANALYSIS, 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 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. IVC FILTER TILT HAS BEEN ASSOCIATED WITH PRACTITIONER TECHNIQUE AND VESSEL ANATOMY, SPECIFICALLY ASYMMETRY AND TORTUOSITY. VESSEL PERFORATION IS A KNOWN ADVERSE EVENT ASSOCIATED WITH IMPLANTING VENA CAVA FILTERS AND IS LISTED AS SUCH IN THE INSTRUCTIONS FOR USE (IFU) AND NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL AND LONG-TERM COMPLICATIONS RELATED TO IVC FILTERS. THE IFU ALSO STATES THAT 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. 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. WITHOUT POST IMPLANT IMAGE REPORTS THE REPORTED EVENTS COULD NOT BE CONFIRMED OR FURTHER CLARIFIED. DUE TO THE NATURE OF THE COMPLAINT THE REPORTED PAIN COULD NOT BE FURTHER CLARIFIED, NOR A CAUSE DETERMINED. PAIN 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.
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 FILTER FRACTURE, PERFORATION, MIGRATION AND TILT. 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 AND SUFFERING, AND OTHER DAMAGES.
ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF NECROTIZING FASCIITIS, PULMONARY EMBOLISM AND DEEP VEIN THROMBOSIS. THE FILTER WAS IMPLANTED VIA THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN USING ULTRASOUND AND FLUOROSCOPIC GUIDANCE. IT WAS DEPLOYED INTO THE INFERIOR VENA CAVA BELOW THE LEVEL OF THE RENAL VEINS UNDER FLUOROSCOPIC OBSERVATION. THE DELIVERY SHEATH WAS THEN REMOVED. THE PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) STATES THAT THE PATIENT EXPERIENCED FRACTURE, INFERIOR VENA CAVA (IVC) PERFORATION, ORGAN PERFORATION, MIGRATION OF ENTIRE FILTER OTHER THAN TO HEART AND FILTER TILT. THE PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY FIFTEEN YEARS AND EIGHT MONTHS AFTER THE INDEX PROCEDURE. THE FORM NOTED THAT THE FRACTURED STRUTS WERE RETAINED IN THE IVC AND LEFT RENAL VEIN. THE PATIENT CONTINUES TO EXPERIENCE LEFT SIDE PAIN RELATED TO THE FILTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280086 | UNKNOWN TRAPEASE | FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | CORDIS CORPORATION | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Life Threatening | UNKNOWN 6 FRENCH FLUSH CATHETER| UNKNOWN 6 FRENCH SHEATH| UNKNOWN DELIVERY SHEATH| UNKNOWN GUIDEWIRE |