CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100)
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Event Date 10/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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Please note that device reported is a trapease vena cava filter and for which the catalog and lot numbers are not currently available.Patient age and medical history were also not provided.If obtained, a follow up report will be submitted within 30 days upon receipt.The device remains implanted and is not available for evaluation.Please note that the contact is not a medical professional but a more accurate choice is not available.It was reported that a patient was treated with a trapease vena cava filter which subsequently malfunctioned and caused blood clots, stenosis, caval thrombosis, deep vein thrombosis, and filter migration.The indication for the filter implant and patient¿s medical history has not been provided.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 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.Blood clots, clotting and/or occlusion and stenosis of the inferior vena cava (ivc) or the filter does not represent a device malfunction.Stenosis is an abnormal narrowing of a vessel.Ivc filters are not indicated for use in the prevention of dvt.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instructions for use (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.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.
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Event Description
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A patient was treated with a trapease vena cava filter which subsequently malfunctioned and caused injury, damage, including, but not limited to blood clots, stenosis, caval thrombosis, deep vein thrombosis, and filter migration.As a direct & proximate result, the patient suffered life-threatening injuries & damages & required extensive medical care & treatment.As a further proximate.Result, the patient has suffered & will suffer significant medical expenses, pain & suffering & other damages.
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Event Description
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As reported in the legal brief, a patient was treated with a trapease vena cava filter which subsequently malfunctioned and caused injury and damage, including, but not limited to, blood clots, stenosis, caval thrombosis, deep vein thrombosis, and filter migration.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the filter was indicated for bilateral deep venous thrombosis (dvt) and pulmonary embolism (pe).Using sonographic guidance, a femoral venous puncture was performed with a needle on the right side.There was no thrombus present in the common femoral vein.A sheath was advanced into the femoral vein and subsequently to the superior vena cava below the confluence of the renal veins with the vena cava.The trapease type vena cava filter was than maneuvered to the appropriate level within the vena cava and deployed.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately twelve years and nine months after the filter implantation.The patient reports filter migration, blood clots, clotting and or occlusion of the inferior vena cava (ivc).The patient further reports swollen legs, open sore that does not heal, use of compression socks and the use of anticoagulation therapy in addition to anxiety related to the filter.
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Manufacturer Narrative
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It was reported that a patient was treated with a trapease vena cava filter which subsequently malfunctioned and caused blood clots, stenosis, caval thrombosis, deep vein thrombosis, and filter migration.The patient reported becoming aware of filter migration, blood clots, clotting and or occlusion of the inferior vena cava (ivc) approximately twelve years and nine months post implant.The patient also reported swollen legs, an open sore that does not heal and anxiety related to the filter.According to the implant record the indication for the filter implant was bilateral deep venous thrombosis (dvt) and pulmonary embolism (pe).The filter was placed via the right femoral vein and maneuvered to the appropriate level within the vena cava and deployed.The patient tolerated the procedure well.There is currently no additional information available for review.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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.Blood clots, clotting and/or occlusion and stenosis of the ivc or the filter does not represent a device malfunction.Stenosis is an abnormal narrowing of a vessel.Ivc filters are not indicated for use in the prevention of dvt.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in swelling of the affected extremity and or venous stasis ulcers that are recalcitrant to healing.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instructions for use (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.Anxiety, leg swelling, and wounds do not represent a device malfunction and may be related to underlying patient specific issues.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.
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