466P306X
Report
- Report Number
- 1016427-2019-03669
- Event Type
- Injury
- Date Received
- December 16, 2019
- Date of Event
- October 9, 2018
- Report Date
- March 18, 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
ACCORDING TO ADDITIONAL INFORMATION PROVIDED IN AN AMENDED PATIENT PROFILE FORM (PPF), THE PATIENT REPORTS SEVERE BACK PAIN AS WELL AS RIGHT AND LEFT ABDOMINAL PAIN.
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. THE PATIENT REPORTED BECOMING AWARE OF FILTER FRACTURE APPROXIMATELY TWELVE YEARS AND EIGHT MONTHS POST IMPLANT. THE PATIENT ALSO REPORTS EXPERIENCING RIGHT AND LEFT ABDOMINAL PAIN AND SEVERE BACK PAIN. THE INDICATION FOR THE FILTER IMPLANT WAS A HIGH RISK FOR PULMONARY EMBOLISM, DESPITE ANTICOAGULATION, IN A MORBIDLY OBESE PATIENT WITH CHRONIC VENOUS INSUFFICIENCY FACING A MAJOR BARIATRIC PROCEDURE. THE FILTER WAS PLACED VIA THE JUGULAR VEIN AND DEPLOYED IN THE STANDARD MANNER. THE PATIENT UNDERWENT OPEN GASTRIC BYPASS SURGERY TWELVE DAYS LATER. 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. 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. DUE TO THE NATURE OF THE COMPLAINT THE REPORTED PAIN ISSUES COULD NOT BE FURTHER CLARIFIED. 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.
ADDITIONAL INFORMATION: SECTION A2 (AGE AT THE TIME OF EVENT, DATE OF BIRTH). SECTION B3 (EVENT DATE). SECTION B4 (EVENT DESCRIPTION). SECTION B7 (RELEVANT MEDICAL HISTORY). SECTION D11 (CONCOMITANT MEDICAL PRODUCTS: NEEDLE, WIRE, INTRODUCER, DILATOR, CATHETER) SECTION G4 (DATE RECEIVED BY THE MANUFACTURER). COMPLAINT CONCLUSION: AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE PATIENT IS REPORTED TO HAVE HAD A HISTORY OF MORBID OBESITY. THE INDICATION FOR THE FILTER PLACEMENT WAS REPORTED TO BE THE PATIENT¿S HIGH RISK FOR PULMONARY EMBOLISM (PE) WITH CHRONIC INSUFFICIENCY DESPITE ADEQUATE ANTICOAGULATION AND PRIOR TO A PLANNED MAJOR GASTRIC BYPASS SURGERY. THE FILTER WAS IMPLANTED VIA THE JUGULAR VEIN AND PLACED WITHOUT COMPLICATIONS. APPROXIMATELY TWELVE YEARS AND EIGHT MONTHS AFTER THE FILTER IMPLANTATION, THE PATIENT BECAME AWARE THAT THE FILTER HAD FRACTURED. 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 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 PROCEDURAL FILMS FOR REVIEW, THE REPORTED FILTER FRACTURE COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. THE TIMING AND MECHANISM OF THE FRACTURE HAS NOT BEEN REPORTED AT THIS TIME. THE INSTRUCTIONS FOR USE (IFU) 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. 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: FILTER FRACTURE. 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 FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED PER MEDICAL RECORDS: THE PATIENT PRESENTED AS HIGH RISK FOR PULMONARY EMBOLISM (PE) WITH CHRONIC VENOUS INSUFFICIENCY PRIOR TO A MAJOR GASTRIC BYPASS PROCEDURE. THE PATIENT IS SAID TO BE MORBIDLY OBESE. USING THE JUGULAR VEIN, THE INFERIOR VENA CAVA (IVC) FILTER WAS DEPLOYED IN PROPER POSITION UNDER FLUOROSCOPIC VISUALIZATION. THE PROCEDURE WAS COMPETED WITH NO COMPLICATIONS NOTED. THE PATIENT UNDERWENT GASTRIC BYPASS TWELVE DAYS LATER. THE PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY TWELVE YEARS AND EIGHT MONTHS POST IMPLANTATION. THE PATIENT REPORTS FILTER FRACTURE. ACCORDING TO ADDITIONAL INFORMATION PROVIDED IN AN AMENDED PATIENT PROFILE FORM (PPF), THE PATIENT REPORTS SEVERE BACK PAIN AS WELL AS RIGHT AND LEFT ABDOMINAL PAIN.
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: FILTER FRACTURE. 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 FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED PER MEDICAL RECORDS: THE PATIENT PRESENTED AS HIGH RISK FOR PE WITH CHRONIC VENOUS INSUFFICIENCY PRIOR TO A MAJOR GASTRIC BYPASS PROCEDURE. THE PATIENT IS SAID TO BE MORBIDLY OBESE. USING THE JUGULAR VEIN, THE IVC FILTER WAS DEPLOYED IN PROPER POSITION UNDER FLUOROSCOPIC VISUALIZATION. THE PROCEDURE WAS COMPETED WITH NO COMPLICATIONS NOTED. THE PATIENT UNDERWENT GASTRIC BYPASS 12 DAYS LATER. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED PER PATIENT PROFILE FORM (PPF): THE PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY 12 YEARS AND 8 MONTHS POST IMPLANTATION. THE PATIENT REPORTS FILTER FRACTURE.
THE CATALOG NUMBER IS UNKNOWN, IF RECEIVED IT WILL BE PROVIDED. COMPLAINT CONCLUSION: 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 THE FILTER HAD FRACTURED. 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 PROCEDURAL FILMS FOR REVIEW, THE REPORTED FILTER FRACTURE COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. THE TIMING AND MECHANISM OF THE FRACTURE HAS NOT BEEN REPORTED AT THIS TIME. THE INSTRUCTIONS FOR USE (IFU) 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. 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: FILTER FRACTURE. 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 |
|---|---|---|---|---|---|---|---|
| 1266124 | 466P306X | FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | CORDIS CASHEL | 466P306X | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Life Threatening | UNK DILATOR, UNK CATHETER.| UNK NEEDLE.| UNK WIRE, UNK INTRODUCER.| UNK. |