466FXXXX
Report
- Report Number
- 1016427-2017-00617
- Event Type
- Injury
- Date Received
- September 26, 2017
- Date of Event
- May 1, 2015
- Report Date
- March 24, 2020
- Manufacturer
- CORDIS CASHEL
- Product Code
- DTK
- PMA / PMN Number
- K034050
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
ADDITIONAL INFORMATION: SECTION A4 (PATIENT WEIGHT) SECTION B3 (EVENT DATE) SECTION B4 (EVENT DESCRIPTION) SECTION B7 (RELEVANT MEDICAL HISTORY) SECTION D11 (CONCOMITANT MEDICAL PRODUCTS: MERIT IQ J TIP WIRE-.035X150CM, MERIT MEDICAL PRELUDE 6FX11CM SHEATH, COOK PIGTAIL CATHETER 5FX 70CM, TERUMO ANGLED GUIDEWIRE STIFF- .035X180CM, MERIT IMA CATHETER 5F-65CM, MERIT AM PERFORMA 5FX65CM CATHETER) SECTION G4 (DATE RECEIVED BY THE MANUFACTURER) SECTION H6 (EVALUATION CODES: ADDITION OF PATIENT CODE 2572 AND DEVICE CODE 2522) EVENT DESCRIPTION: AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE FILTER. THE DEVICE SUBSEQUENTLY MALFUNCTIONED BY, INTER ALIA, EMBEDDING OR PERFORATING THE PATIENT¿S VASCULATURE AND CAUSING CHRONIC THROMBUS AND OCCLUSIONS. THE PATIENT UNDERWENT A FAILED RETRIEVAL ATTEMPT OF THE DEVICE AND IS CONTINUING TO SUFFER COMPLICATIONS CAUSED BY THE DEVICE. PER AMENDED SHORT FORM, THE PATIENT ALSO REPORTS CLOGGED FILTER, FAILED REMOVAL ATTEMPT DUE TO EMBEDDED FILTER, AND DVT. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED PER MEDICAL RECORDS: THE PATIENT HAS A HISTORY OF PROTEIN C DEFICIENCY, DEEP VEIN THROMBOSIS (DVT), DUE TO A MOTOR-CYCLE ACCIDENT, AND BILATERAL PULMONARY EMBOLISM (PE)- 2009, NON-COMPLIANT WITH MEDICATIONS, HYPERTENSION, ETOH AND TOBACCO ABUSE. PRIOR TO THE FILTER PLACEMENT, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH LEFT LEG PAIN AND SWELLING TIMES 4 DAYS. THE PATIENT HAD NOT BEEN TAKING COUMADIN FOR THE PAST 5 MONTHS DUE TO THE COST. A DOPPLER ULTRASOUND OF THE LEFT LOWER EXTREMITY SHOWED THROMBUS FROM THE ANKLE THROUGH THE COMMON ILIAC TO ABOUT 10CM BELOW THE UMBILICUS. THE INDICATION FOR THE FILTER PLACEMENT WAS HIGH RISK FOR PE FROM EXTENSIVE DVT. THE FILTER WAS PLACED VIA THE RIGHT COMMON FEMORAL VEIN AND DEPLOYED IN THE INFRARENAL INFERIOR VENA CAVA (IVC). THE PHYSICIAN NOTED THAT THE FILTER DEPLOYED REASONABLY VERTICAL, BUT THE REMOVAL HOOK WAS TILTED SOMEWHAT TOWARDS THE RIGHT SIDE OF THE IVC. GIVEN THE EXTREME EXTENT OF THE DVT THE PHYSICIAN DID NOT THINK IT WOULD BE FEASIBLE TO PERFORM THROMBECTOMY OR THROMBOLYSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON COUMADIN AND LOVENOX INJECTIONS. APPROXIMATELY FIVE YEARS POST IMPLANT, THE PATIENT PRESENTED TO THE ER WITH COMPLAINTS OF LEFT LOWER EXTREMITY (LLE) PAIN AND SWELLING. THE PATIENT WAS NOTED TO HAVE DISCOLORATION OF THE LEG AND A FEW ULCERATIONS WITH CLEAR DRAINAGE, WOUND CULTURES WERE POSITIVE FOR STREP PYOGENES AND THE PATIENT WAS TREATED WITH NAFCILLIN. BILATERAL DUPLEX VENOUS ULTRASOUND SHOWED SUBACUTE TO CHRONIC DVT IN THE LLE, NO DVT IN THE RLE. APPROXIMATELY 10 DAYS LATER, A COMPUTED TOMOGRAPHY (CT) SCAN OF THE LLE SHOWED EXTENSIVE VENOUS ENGORGEMENT AND COLLATERALS IN THE LE CONSISTENT WITH CHRONIC PROXIMAL OBSTRUCTION. APPROXIMATELY 2 DAYS LATER, A PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER WAS PLACED. ON THE FOLLOWING DAY, A LLE VENOGRAM WAS PERFORMED AND SHOWED THAT THE FILTER IS THROMBOSES AND IS OCCLUDING THE IVC CHRONICALLY. THERE IS CHRONIC OCCLUSION OF THE PROXIMAL LEFT COMMON ILIAC VEIN AND IVC AT THE LEVEL OF AND IMMEDIATELY INFERIOR TO THE INDWELLING IVC FILTER. INNUMERABLE COLLATERAL VEINS (LUMBAR VEINS DRAINING INTO THE HEMIAZYGOS SYSTEM) ARE NOTED IN THE REGION OF THE INFERIOR IVC/PROXIMAL LEFT COMMON ILIAC VEINS. THE IVC ABOVE THE FILTER APPEARS PATENT. THE LEFT COMMON FEMORAL, FEMORAL, AND POPLITEAL VEINS ARE PATENT. SEVERAL COLLATERAL VESSELS ARE ALSO NOTED IN THE REGION OF THE LEFT FEMORAL VEIN. A CT SCAN OF THE ABDOMEN AND PELVIS PERFORMED THAT DAY SHOWED THROMBOSED IVC FILTER AND NEAR COMPLETE OCCLUSION OF THE IVC, WITH COLLATERALS PRESENT. INFRARENAL IVC NEAR-OCCLUSION IS SEEN, DUE TO LARGE AMOUNT OF THROMBUS IN THE IVC FILTER. ASSOCIATED WITH THIS, THERE ARE VERY NUMEROUS RETROPERITONEAL, AZYGOS/HEMIAZYGOS, AND VENTRAL ABDOMINAL WALL (INCLUDING PROMINENT INFERIOR EPIGASTRIC) VENOUS COLLATERALS ARE SEEN. A SMALL HOOK IS SEEN AT THE CAUDAL ASPECT OF THE IVC FILTER BUT NOT AT ITS SUPERIOR ASPECT. THERE APPEARS TO BE RELATIVE NARROWING OF THE IVC AT THE LEVEL JUST CAUDAL TO THE IVC FILTER, BUT UNCERTAIN WHETHER NOT THIS IS RELATED TO HYDRATION STATUS. THE FOLLOWING DAY, AN IVC FILTER REMOVAL ATTEMPT VIA JUGULAR APPROACH WAS ATTEMPTED BY INTERVENTIONAL RADIOLOGY, HOWEVER, WAS UNSUCCESSFUL. ACCESS WAS GAINED VIA THE RIGHT INTERNAL JUGULAR VEIN AND THE RIGHT COMMON FEMORAL VEIN. SEVERAL ATTEMPTS WERE MADE TO SNARE THE INFERIORLY POSITIONED HOOK OF THE FILTER, HOWEVER IT WAS UNSUCCESSFUL. ATTEMPTED RETRIEVAL WITH ALLIGATOR FORCEPS AND RETRIEVAL FORMING A LOOP SNARE FROM ABOVE WERE ALSO UNSUCCESSFUL. WAS NOTATION WAS MADE OF MULTIPLE VENOUS COLLATERALS AROUND THIS OCCLUSION AND NON-OCCLUSIVE LEFT COMMON FEMORAL VEIN THROMBUS, NON-OCCLUSIVE THROMBUS IN THE RIGHT COMMON FEMORAL VEIN. THE PATIENT WAS DISCHARGED 2 DAYS LATER, DISCHARGE DIAGNOSES WERE NOTED AS CELLULITIS, SEPTIC THROMBOPHLEBITIS, NON-HEALING ULCER ON THE MEDIAL SURFACE OF THE RIGHT ANKLE AND STREP PYOGENES WOUND INFECTION. APPROXIMATELY 30 DAYS LATER, THE PATIENT PRESENTED TO THE ER WITH INCREASED LLE SWELLING AND RIGHT THIGH SWELLING. THE PATIENT STATED THAT THERE HAS BEEN LEFT LEG SWELLING AND PROBLEMS SINCE AN ACCIDENT 15 YEARS PRIOR. WOUND CARE WAS CONSULTED FOR THE LEFT LEG AND THE PATIENT WAS DISCHARGED 2 DAYS LATER. APPROXIMATELY 3 MONTHS LATER, THE PATIENT PRESENTED TO THE ER WITH COMPLAINTS OF LEG AND CHEST PAIN WITH SHORTNESS OF BREATH. WORKUP DURING THIS VISIT WAS NEGATIVE FOR PE AND ANY CARDIAC EVENT AND THE PATIENT WAS DISCHARGED TO HOME. APPROXIMATELY 5 MONTHS LATER, THE PATIENT PRESENTED TO THE ER WITH COMPLAINTS OF FLANK PAIN, HEMATURIA AND DYSURIA. THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION AND DISCHARGED TO HOME WITH PRESCRIPTIONS AND INSTRUCTIONS TO FOLLOW UP WITH PRIMARY CARE PHYSICIAN. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED PER PATIENT PROFILE FORM (PPF): THE PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY 5 YEARS POST IMPLANTATION. THE PATIENT REPORTS DEVICE EMBEDMENT AND AN UNSUCCESSFUL PERCUTANEOUS REMOVAL PROCEDURE. THE PATIENT ALSO REPORTS SUFFERING FROM ANXIETY. COMPLAINT CONCLUSION: IT WAS REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE INFORMATION PROVIDED INDICATED THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED A CLOGGED FILTER, A FAILED REMOVAL ATTEMPT, DUE TO AN EMBEDDED FILTER, AND DEEP VEIN THROMBOSIS (DVT). PER AMENDED SHORT FORM, THE PATIENT ALSO REPORTS CLOGGED FILTER AND A FAILED REMOVAL ATTEMPT DUE TO EMBEDDED FILTER, AND DVT. ACCORDING TO THE PATIENT PROFILE FORM, THE PATIENT BECAME AWARE OF EMBEDMENT AND AN UNSUCCESSFUL PERCUTANEOUS REMOVAL ATTEMPT APPROXIMATELY FIVE YEARS POST IMPLANT. THE PATIENT ALSO REPORTED EXPERIENCING ANXIETY. ACCORDING TO THE MEDICAL RECORDS THE PATIENT HISTORY IS SIGNIFICANT FOR PROTEIN C DEFICIENCY, DVT, DUE TO A MOTOR-CYCLE ACCIDENT, AND BILATERAL PULMONARY EMBOLISM (PE), NON-COMPLIANT WITH MEDICATIONS, HYPERTENSION, ETOH AND TOBACCO ABUSE. PRIOR TO THE FILTER PLACEMENT, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH LEFT LEG PAIN AND SWELLING TIMES 4 DAYS. THE PATIENT HAD NOT BEEN TAKING COUMADIN FOR THE PAST 5 MONTHS DUE TO THE COST. A DOPPLER ULTRASOUND OF THE LEFT LOWER EXTREMITY SHOWED THROMBUS FROM THE ANKLE THROUGH THE COMMON ILIAC TO ABOUT 10CM BELOW THE UMBILICUS. THE INDICATION FOR THE FILTER PLACEMENT WAS HIGH RISK FOR PE FROM EXTENSIVE DVT. THE FILTER WAS PLACED VIA THE RIGHT COMMON FEMORAL VEIN AND DEPLOYED IN THE INFRARENAL INFERIOR VENA CAVA (IVC). THE PHYSICIAN NOTED THAT THE FILTER DEPLOYED REASONABLY VERTICAL, BUT THE REMOVAL HOOK WAS TILTED SOMEWHAT TOWARDS THE RIGHT SIDE OF THE IVC. GIVEN THE EXTREME EXTENT OF THE DVT THE PHYSICIAN DID NOT THINK IT WOULD BE FEASIBLE TO PERFORM THROMBECTOMY OR THROMBOLYSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON COUMADIN AND LOVENOX INJECTIONS. APPROXIMATELY FIVE YEARS POST IMPLANT, THE PATIENT PRESENTED TO THE ER WITH COMPLAINTS OF LEFT LOWER EXTREMITY (LLE) PAIN AND SWELLING. THE PATIENT WAS NOTED TO HAVE DISCOLORATION OF THE LEG AND A FEW ULCERATIONS WITH CLEAR DRAINAGE, WOUND CULTURES WERE POSITIVE FOR STREP PYOGENES AND THE PATIENT WAS TREATED WITH NAFCILLIN. BILATERAL DUPLEX VENOUS ULTRASOUND SHOWED SUBACUTE TO CHRONIC DVT IN THE LLE, NO DVT IN THE RLE. APPROXIMATELY 10 DAYS LATER, A COMPUTED TOMOGRAPHY (CT) SCAN OF THE LLE SHOWED EXTENSIVE VENOUS ENGORGEMENT AND COLLATERALS IN THE LE CONSISTENT WITH CHRONIC PROXIMAL OBSTRUCTION. APPROXIMATELY 2 DAYS LATER, A PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER WAS PLACED. ON THE FOLLOWING DAY, AN LLE VENOGRAM WAS PERFORMED AND SHOWED THAT THE FILTER IS THROMBOSES AND IS OCCLUDING THE IVC CHRONICALLY. THERE IS CHRONIC OCCLUSION OF THE PROXIMAL LEFT COMMON ILIAC VEIN AND IVC AT THE LEVEL OF AND IMMEDIATELY INFERIOR TO THE INDWELLING FILTER. INNUMERABLE COLLATERAL VEINS (LUMBAR VEINS DRAINING INTO THE HEMIAZYGOS SYSTEM) ARE NOTED IN THE REGION OF THE INFERIOR IVC/PROXIMAL LEFT COMMON ILIAC VEINS. THE IVC ABOVE THE FILTER APPEARS PATENT. THE LEFT COMMON FEMORAL, FEMORAL, AND POPLITEAL VEINS ARE PATENT. SEVERAL COLLATERAL VESSELS ARE ALSO NOTED IN THE REGION OF THE LEFT FEMORAL VEIN. A CT SCAN OF THE ABDOMEN AND PELVIS PERFORMED THAT DAY SHOWED THROMBOSED IVC FILTER AND NEAR COMPLETE OCCLUSION OF THE IVC, WITH COLLATERALS PRESENT. INFRARENAL IVC NEAR-OCCLUSION IS SEEN, DUE TO LARGE AMOUNT OF THROMBUS IN THE IVC FILTER. ASSOCIATED WITH THIS, THERE ARE VERY NUMEROUS RETROPERITONEAL, AZYGOS/HEMIAZYGOS, AND VENTRAL ABDOMINAL WALL (INCLUDING PROMINENT INFERIOR EPIGASTRIC) VENOUS COLLATERALS ARE SEEN. A SMALL HOOK IS SEEN AT THE CAUDAL ASPECT OF THE IVC FILTER BUT NOT AT ITS SUPERIOR ASPECT. THERE APPEARS TO BE RELATIVE NARROWING OF THE IVC AT THE LEVEL JUST CAUDAL TO THE IVC FILTER, BUT UNCERTAIN WHETHER NOT THIS IS RELATED TO HYDRATION STATUS. THE FOLLOWING DAY, AN UNSUCCESSFUL REMOVAL ATTEMPT VIA JUGULAR APPROACH WAS ATTEMPTED BY INTERVENTIONAL RADIOLOGY. ACCESS WAS GAINED VIA THE RIGHT INTERNAL JUGULAR VEIN AND THE RIGHT COMMON FEMORAL VEIN. SEVERAL ATTEMPTS WERE MADE TO SNARE THE INFERIORLY POSITIONED HOOK OF THE FILTER, HOWEVER IT WAS UNSUCCESSFUL. ATTEMPTED RETRIEVAL WITH ALLIGATOR FORCEPS AND RETRIEVAL FORMING A LOOP SNARE FROM ABOVE WERE ALSO UNSUCCESSFUL. NOTATION WAS MADE OF MULTIPLE VENOUS COLLATERALS AROUND THIS OCCLUSION AND NON-OCCLUSIVE LEFT COMMON FEMORAL VEIN THROMBUS, NON-OCCLUSIVE THROMBUS IN THE RIGHT COMMON FEMORAL VEIN. THE PATIENT WAS DISCHARGED 2 DAYS LATER, DISCHARGE DIAGNOSES WERE NOTED AS CELLULITIS, SEPTIC THROMBOPHLEBITIS, NON-HEALING ULCER ON THE MEDIAL SURFACE OF THE RIGHT ANKLE AND STREP PYOGENES WOUND INFECTION. APPROXIMATELY 30 DAYS LATER, THE PATIENT PRESENTED TO THE ER WITH INCREASED LLE SWELLING AND RIGHT THIGH SWELLING. THE PATIENT STATED THAT THERE HAS BEEN LEFT LEG SWELLING AND PROBLEMS SINCE AN ACCIDENT 15 YEARS PRIOR. WOUND CARE WAS CONSULTED FOR THE LEFT LEG AND THE PATIENT WAS DISCHARGED 2 DAYS LATER. APPROXIMATELY 3 MONTHS LATER, THE PATIENT PRESENTED TO THE ER WITH COMPLAINTS OF LEG AND CHEST PAIN WITH SHORTNESS OF BREATH. WORKUP DURING THIS VISIT WAS NEGATIVE FOR PE AND ANY CARDIAC EVENT AND THE PATIENT WAS DISCHARGED TO HOME. APPROXIMATELY 5 MONTHS LATER, THE PATIENT PRESENTED TO THE ER WITH COMPLAINTS OF FLANK PAIN, HEMATURIA AND DYSURIA AND WAS DIAGNOSED WITH A URINARY TRACT INFECTION. 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 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. RETRIEVAL OF THE OPTEASE VENA CAVA FILTER IS INDICATED, IN THE US, UP TO 14 DAYS POST IMPLANT. THE PREDOMINANT CONCERN IS THE DEVELOPMENT OF ENDOTHELIALIZATION, WHICH WOULD MAKE SUBSEQUENT REMOVAL DIFFICULT. ENDOTHELIALIZATION HAS BEEN SHOWN TO LEAD TO EXPLANT PROBLEMS AFTER AS SHORT A PERIOD AS 12 DAYS. BLOOD CLOTS AND OCCLUSIVE THROMBOSIS WITHIN THE FILTER AND/OR VASCULATURE DO NOT REPRESENT A DEVICE MALFUNCTION. COLLATERAL CIRCULATION IS THE CREATION OF NEW VESSELS TO REESTABLISH CIRCULATION THROUGH ENLARGEMENT OF MINOR VESSELS AND ANASTOMOSIS OF VESSELS WITH THOSE ADJACENT PARTS WHEN A MAJOR VEIN OR ARTERY IS FUNCTIONALLY IMPAIRED. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND VESSEL CHARACTERISTICS. IVC FILTERS ARE NOT INDICATED FOR USE IN THE PREVENTION OF DVT. IVC TILT WAS NOTED DURING IMPLANT. FILTER TILT HAS BEEN ASSOCIATED WITH VESSEL CHARACTERISTICS, SPECIFICALLY ASYMMETRY, TORTUOSITY AND TECHNIQUE. ANXIETY DOES NOT REPRESENT A DEVICE MALFUNCTION AND MAY BE RELATED TO UNDERLYING PATIENT SPECIFIC ISSUES. WITH THE LIMITED INFORMATION PROVIDED A CLINICAL DETERMINATION CANNOT BE MADE AS TO WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. 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.
SEE H10.
COMPLAINT CONCLUSION: IT WAS REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE INFORMATION PROVIDED INDICATED THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED EMBEDDING OR PERFORATING THE PATIENT¿S VASCULATURE AND CAUSING CHRONIC THROMBUS AND OCCLUSIONS. THE PATIENT UNDERWENT A FAILED RETRIEVAL ATTEMPT OF THE DEVICE AND IS CONTINUING TO SUFFER COMPLICATIONS CAUSED BY THE DEVICE. ACCORDING TO THE INFORMATION RECEIVED IN THE AMENDED SHORT FORM, THE PATIENT ALSO REPORTS A CLOGGED FILTER, A FAILED REMOVAL ATTEMPT, DUE TO AN EMBEDDED FILTER, AND DEEP VEIN THROMBOSIS (DVT). THE INDICATION FOR THE FILTER PLACEMENT HAS NOT BEEN PROVIDED AND 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 OPTEASE 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. RETRIEVAL OF THE OPTEASE VENA CAVA FILTER IS INDICATED, IN THE US, UP TO 14 DAYS POST IMPLANT. THE PREDOMINANT CONCERN IS THE DEVELOPMENT OF ENDOTHELIALIZATION, WHICH WOULD MAKE SUBSEQUENT REMOVAL DIFFICULT. ENDOTHELIALIZATION HAS BEEN SHOWN TO LEAD TO EXPLANT PROBLEMS AFTER AS SHORT A PERIOD AS 12 DAYS. BLOOD CLOTS AND OCCLUSIVE THROMBOSIS WITHIN THE FILTER AND/OR VASCULATURE DO NOT REPRESENT A DEVICE MALFUNCTION. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION CHARACTERISTICS. IVC FILTERS ARE NOT INDICATED FOR USE IN THE PREVENTION OF DVT. PERFORATION OF THE IVC WAS REPORTED, HOWEVER A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. WITHOUT POST IMPLANT IMAGES FOR REVIEW, THE REPORTED FILTER PERFORATION COULD NOT BE CONFIRMED NOR A CAUSE FOR THE EVENT DETERMINED. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL AND LONG-TERM COMPLICATIONS ASSOCIATED WITH IVC FILTERS. WITH THE LIMITED INFORMATION PROVIDED A CLINICAL DETERMINATION CANNOT BE MADE AS TO WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. 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.
AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE FILTER. THE DEVICE SUBSEQUENTLY MALFUNCTIONED BY, INTER ALIA, EMBEDDING OR PERFORATING THE PATIENT¿S VASCULATURE AND CAUSING CHRONIC THROMBUS AND OCCLUSIONS. THE PATIENT UNDERWENT A FAILED RETRIEVAL ATTEMPT OF THE DEVICE, AND IS A CONTINUING TO SUFFER COMPLICATIONS CAUSED BY THE DEVICE. THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, LOSS OF ENJOYMENT OF LIFE, DISABILITY, AND OTHER LOSSES. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT 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. BLOOD CLOTS AND OCCLUSION WITHIN THE IVC DOES NOT REPRESENT A DEVICE MALFUNCTION. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION CHARACTERISTICS. WITHOUT PROCEDURAL FILMS FOR REVIEW, THE REPORTED RETRIEVAL DIFFICULTY COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. RETRIEVAL OF THE OPTEASE VENA CAVA FILTER IS INDICATED UP TO 23 DAYS POST IMPLANTATION. USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S INSTRUCTIONS FOR USE (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, REMODELING/RESTRUCTURING OF THE VESSEL WALL FOLLOWING DEVICE IMPLANTATION, IS THE BODY¿S NATURAL RESPONSE AND HAS BEEN SHOWN TO OCCUR IN AS SHORT A PERIOD AS 12 DAYS. THE BRIEF ALSO REPORTED PERFORATION OF THE PATIENT¿S VASCULATURE; HOWEVER, A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. THE PATIENT¿S SAFETY INFORMATION 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 MANUFACTURING PROCESS OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.
AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE FILTER. THE DEVICE SUBSEQUENTLY MALFUNCTIONED BY, INTER ALIA, EMBEDDING OR PERFORATING THE PATIENT¿S VASCULATURE AND CAUSING CHRONIC THROMBUS AND OCCLUSIONS. THE PATIENT UNDERWENT A FAILED RETRIEVAL ATTEMPT OF THE DEVICE AND IS CONTINUING TO SUFFER COMPLICATIONS CAUSED BY THE DEVICE. THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, LOSS OF ENJOYMENT OF LIFE, DISABILITY, AND OTHER LOSSES. ACCORDING TO THE INFORMATION RECEIVED IN THE AMENDED SHORT FORM, THE PATIENT ALSO REPORTS CLOGGED FILTER, FAILED REMOVAL ATTEMPT DUE TO EMBEDDED FILTER, AND DVT.
AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE FILTER. THE DEVICE SUBSEQUENTLY MALFUNCTIONED BY, INTER ALIA, EMBEDDING OR PERFORATING THE PATIENT¿S VASCULATURE AND CAUSING CHRONIC THROMBUS AND OCCLUSIONS. THE PATIENT UNDERWENT A FAILED RETRIEVAL ATTEMPT OF THE DEVICE, AND IS A CONTINUING TO SUFFER COMPLICATIONS CAUSED BY THE DEVICE. THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING, LOSS OF ENJOYMENT OF LIFE, DISABILITY, AND OTHER LOSSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675640 | 466FXXXX | FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | CORDIS CASHEL | 466FXXXX | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |