466FXXXX
Report
- Report Number
- 1016427-2018-01034
- Event Type
- Injury
- Date Received
- January 19, 2018
- Date of Event
- April 9, 2013
- Report Date
- May 13, 2019
- Manufacturer
- CORDIS CASHEL
- Product Code
- DTK
- PMA / PMN Number
- K034050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, CAVAL THROMBOSIS, LIFETIME ANTICOAGULATION POST-IMPLANT, DEEP VEIN THROMBOSIS (DVT), AND THROMBOSIS/EMBOLISM. 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 DEVICE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS THE STERILE LOT NUMBER WAS NOT PROVIDED. 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. DVT OCCURS WHEN A BLOOD CLOT FORMS IN A DEEP VEIN AND IS MOST COMMON IN THE DEEP VEINS OF THE LOWER LEG (CALF), AND CAN SPREAD UP TO THE VEINS IN THE THIGH. PLACEMENT OF A VENA CAVA FILTER IS NOT A CURE FOR DVT NOR DOES IT PREVENT THE FORMATION OF DVT OR OTHER CLOTS (THROMBOSIS). FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION. THERE IS NO MEDICAL EVIDENCE OF A CAUSAL RELATIONSHIP BETWEEN THE VENA CAVA FILTER AND THE FORMATION OF NEW DVT AND THROMBOSIS. 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 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, THE PATIENT HAD PLACEMENT OF OPTEASE INFERIOR VENA CAVA (IVC) FILTER. PER THE MEDICAL RECORDS, THE PRE-OPERATIVE DIAGNOSIS WAS RECURRENT PULMONARY EMBOLUS WITH LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS WHILE FULLY ANTICOAGULATED. AN OPTEASE IVC FILTER WAS DEPLOYED APPROPRIATELY WITH THE TIP AT THE L2. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, CAVAL THROMBOSIS, LIFETIME ANTICOAGULATION POST-IMPLANT, DEEP VEIN THROMBOSIS (DVT), AND THROMBOSIS/EMBOLISM. PER THE PATIENT PROFILE FORM (PPF), THE PATIENT REPORTS PERFORATION OF THE FILTER STRUTS OUTSIDE OF THE IVC, THE FILTER HAS ALSO TILTED, HAS BLOOD CLOTS/CLOTTING AND OR OCCLUSION OF THE IVC, UNABLE TO BE RETRIEVED AND POST-IMPLANT PE/DVT. THERE WERE NO DOCUMENTED ATTEMPTS TO REMOVE THE FILTER. A VENOCAVAGRAM, APPROXIMATELY 7 YEARS AFTER FILTER PLACEMENT, INDICATED THE FILTER WITH SEMI ACUTE CLOTS IN BOTH SYSTEMS, DOCUMENTING CAVAL THROMBOSIS AND THROMBOSIS/EMBOLISM WHICH LED TO THROMBOTIC TREATMENT. THE PATIENT ALSO REPORTS THE DEVICE IS UNABLE TO BE RETRIEVED, AND ANXIETY, DEPRESSION AND STRESS. 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 OPTEASE 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 PREDOMINANT CONCERN FOR EMBEDDING WITH IN THE WALL OF THE IVC IS THE DEVELOPMENT OF ENDOTHELIALIZATION. ENDOTHELIALIZATION IS THE THE HEALING OF THE INNER SURFACES OF VESSELS OR GRAFTS BY ENDOTHELIAL CELLS. THIS IS THE NORMAL PROCESS WHEREBY THE BODY HEALS AND RECOVERS FROM INVASIVE PROCEDURES. ENDOTHELIALIZATION HAS BEEN SHOWN TO OCCUR IN AS SHORT A PERIOD AS 12 DAYS. WITHOUT PROCEDURAL FILMS FOR REVIEW, THE FILTER TILT REPORTED COULD NOT BE CONFIRMED. ADDITIONALLY, THE TIMING AND MECHANISM OF THE FILTER TILT IS UNKNOWN. IVC FILTER TILT HAS BEEN ASSOCIATED WITH THE ANATOMY OF THE VESSEL, SPECIFICALLY ASYMMETRY AND TORTUOUSNESS. 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. BLOOD CLOTS AND OCCLUSIVE THROMBOSIS WITHIN THE FILTER AND VASCULATURE DO NOT REPRESENT A DEVICE MALFUNCTION. POST PROCEDURAL PULMONARY EMBOLISM IS A KNOWN POTENTIAL EVENT ASSOCIATED WITH THE FILTER DEVICE, PATENT SPECIFIC ISSUES, SPECIFICALLY THE UNDERLYING CAUSES OF THROMBUS FORMATION, MAY CONTRIBUTE TO THESE EVENTS. 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.
PATIENT CORRECTIONS- 1528 IS NOT APPLICABLE AND IS REPLACED WITH DEVICE EMBEDDED IN VESSEL OR PLAQUE (1804), IVC OCCLUSION (1984) AND POST PROCEDURAL PULMONARY EMBOLISM (1829). ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
ADDITIONAL DETAILS WERE RECEIVED FROM THE PATIENT PROFILE THE PATIENT PRESENTED HERSELF FOR A VENACAVAGRAM APPROXIMATELY 7 YEARS AFTER FILTER PLACEMENT WHICH INDICATED THE FILTER SEMI ACUTE CLOTS IN BOTH SYSTEMS DOCUMENTING CAVAL THROMBOSIS AND THROMBOSIS/EMBOLISM WHICH LED TO THROMBOTIC TREATMENT. THE PATIENT ALSO CLAIMS THAT THE DEVICE IS UNABLE TO BE RETRIEVED. THESE INJURIES HAVE CAUSED EMOTIONAL DISTRESS, MENTAL ANGUISH, ANXIETY AND STRESS. MEDICAL RECORDS RECEIVED INDICATE AT FILTER PLACEMENT, THE PRE-OPERATIVE DIAGNOSIS WAS RECURRENT PULMONARY EMBOLUS WITH LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS. THE PATIENT HAD BEEN HOSPITALIZED AND FULLY ANTICOAGULATED. UPON DISCHARGE SHE HAD PALPITATIONS AND REPEAT CT SCAN OF THE CHEST SHOWED FURTHER PULMONARY EMBOLUS. THE PATIENT WAS TAKEN OFF COUMADIN ANTICOAGULATION AND WAS STARTED ON A HEPARIN DRIP. AN OPTEASE IVC FILTER WAS DEPLOYED APPROPRIATELY WITH THE TIP AT THE L2. (B)(4).
AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF OPTEASE INFERIOR VENA CAVA (IVC) FILTER. MEDICAL RECORDS RECEIVED INDICATE AT THE TIME OF FILTER PLACEMENT, THE PRE-OPERATIVE DIAGNOSIS WAS RECURRENT PULMONARY EMBOLUS WITH LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS. THE PATIENT HAD BEEN HOSPITALIZED AND FULLY ANTICOAGULATED. UPON DISCHARGE SHE HAD PALPITATIONS AND REPEAT CT SCAN OF THE CHEST SHOWED FURTHER PULMONARY EMBOLUS. THE PATIENT WAS TAKEN OFF COUMADIN ANTICOAGULATION AND WAS STARTED ON A HEPARIN DRIP. AN OPTEASE IVC FILTER WAS DEPLOYED APPROPRIATELY WITH THE TIP AT THE L2. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, CAVAL THROMBOSIS, LIFETIME ANTICOAGULATION POST-IMPLANT, DEEP VEIN THROMBOSIS (DVT), AND THROMBOSIS/EMBOLISM. 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. PER THE PATIENT PROFILE FORM (PPF), THE PATIENT PRESENTED HERSELF FOR A VENACAVOGRAM APPROXIMATELY 7 YEARS AFTER FILTER PLACEMENT WHICH INDICATED THE FILTER SEMI ACUTE CLOTS IN BOTH SYSTEMS DOCUMENTING CAVAL THROMBOSIS AND THROMBOSIS/EMBOLISM WHICH LED TO THROMBOTIC TREATMENT. THE PATIENT ALSO CLAIMS THAT THE DEVICE IS UNABLE TO BE RETRIEVED. THE FILTER REMAINS IMPLANTED; THUS, UNAVAILABLE FOR ANALYSIS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS THE STERILE LOT NUMBER WAS NOT PROVIDED. THE OPTEASE 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. WITHOUT PROCEDURAL FILMS FOR REVIEW, THE REPORTED EMBEDDED IN IVC WALL AND RETRIEVAL DIFFICULTY COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. RETRIEVAL OF THE OPTEASE VENA CAVA FILTER IS INDICATED, IN THE US, UP TO 14 DAYS POST IMPLANTATION. USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S IFU MAY INVOLVE ADDITIONAL RISKS NOT DESCRIBED IN THE LABELING. THE PREDOMINANT CONCERN IS THE DEVELOPMENT OF ENDOTHELIALIZATION, WHICH WOULD MAKE SUBSEQUENT REMOVAL DIFFICULT. ENDOTHELIALIZATION HAS BEEN SHOWN TO LEAD TO EXPLANTATION PROBLEMS AFTER AS SHORT A PERIOD AS 12 DAYS. BLOOD CLOTS, THROMBOSIS AND OCCLUSIVE THROMBOSIS WITHIN THE FILTER AND VASCULATURE DO NOT REPRESENT A DEVICE MALFUNCTION. 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.
ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, CAVAL THROMBOSIS, LIFETIME ANTICOAGULATION POST-IMPLANT, DEEP VEIN THROMBOSIS (DVT), AND THROMBOSIS/EMBOLISM. 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 |
|---|---|---|---|---|---|---|---|
| 50668 | 466FXXXX | FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | CORDIS CASHEL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Life Threatening| S |