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| Catalog Number 466P306AU |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Occlusion (1984); Swelling (2091); Thrombosis (2100); Perforation of Vessels (2135); Ulcer (2274); Obstruction/Occlusion (2422); Vascular System (Circulation), Impaired (2572); No Code Available (3191)
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| Event Date 07/13/2017 |
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Event Type
Injury
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Manufacturer Narrative
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As reported by the legal brief the patient underwent placement of defendants' trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, thrombosis and occlusion of the ivc below the filter, venous insufficiency, lower leg swelling, and venous stasis ulcers.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 product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The optease 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.Thrombosis, venous insufficiency, swelling of the legs, venous stasis ulcer and occlusion within the filter does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).The instructions for use (ifu) note vessel injuries and recurrent pulmonary embolism as possible long-term complications associated with filter implantation.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.
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Event Description
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As reported by the legal brief the patient underwent placement of defendants' trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, thrombosis and occlusion of the ivc below the filter, venous insufficiency, lower leg swelling, and venous stasis ulcers.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.
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Manufacturer Narrative
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As reported, the patient underwent placement of a trapease inferior vena cava filter.Per the patient profile form (ppf), the device was implanted due to left leg deep vein thrombosis.The patient was reported to have tolerated the index procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, thrombosis and occlusion of the ivc below the filter, venous insufficiency, lower leg swelling, and venous stasis ulcers.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 patient is reported to have experienced the device being embedded in the ivc, collateral veins, discoloration of the legs, pain in the legs, and is reported to continue to experience anxiety related to the device.The filter remains implanted; thus, unavailable for analysis.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 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Venous insufficiency, swelling of the legs, venous stasis ulcer, collateral circulation, skin discoloration and pain in the legs do not represent device malfunctions and maybe related to underlying patient issues.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.
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Manufacturer Narrative
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Concomitant devices: unknown guidewire, unknown introducer, unknown dilator complaint conclusion: as reported, the patient had placement of a trapease inferior vena cava (ivc) filter.The filter was implanted due to left leg deep vein thrombosis.The patient was reported to have tolerated the index procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, thrombosis and occlusion of the ivc below the filter, venous insufficiency, lower leg swelling, and venous stasis ulcers.Per the patient profile form (ppf), the patient reports blood clots, clotting and or occlusion of the inferior vena cava (ivc), device unable to be retrieved, leg (le) edema, collateral veins, venous stasis, legs black.The patient symptom and injuries include, but are not limited to ivc thrombosis, severe leg swelling, leg pain and the ivc filter cannot be removed, although filter retrieval attempt details were not provided.The irretrievable filter also subjects the patient to the ongoing risk of deep vein thrombosis (dvt) and thrombosis of the lower body.The patient further reports severe fear, stress, anxiety and loss of enjoyment of life.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 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Venous insufficiency, swelling of legs, venous stasis ulcer, collateral circulation, and skin discoloration are known potential events associated with both the ivc filters and the underlying coagulopathies that can be indications for filter placement.Anxiety and pain do 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.
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Event Description
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As reported in the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, thrombosis and occlusion of the ivc below the filter, venous insufficiency, lower leg swelling, and venous stasis ulcers.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 following additional information received per the patient profile form (ppf) indicates the device was implanted due to left leg deep vein thrombosis.The patient was reported to have tolerated the index procedure well.The patient is reported to have experienced the device being embedded in the ivc, collateral veins, discoloration of the legs, pain in the legs, and is reported to continue to experience anxiety related to the device.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately seven years and four months post implantation.The patient reports blood clots, clotting and or occlusion of the inferior vena cava (ivc), device unable to be retrieved, leg (le) edema, collateral veins, venous stasis, legs black.The patient symptom and injuries include, but are not limited to ivc thrombosis, severe leg swelling, leg pain and the ivc filter cannot be removed, although filter retrieval attempt details were not provided.The irretrievable filter also subjects the patient to the ongoing risk of deep vein thrombosis (dvt) and thrombosis of the lower body.The filter poses a progressive risk of perforation of the vena cava and surrounding vital organs, vessels and structures, which can result is severe pain and threatening complications.It also poses an increased and progressive risk of migration and fracture causing serious injury and death.The patient further reports living with the possibility that these complications can happen at any moment, which has led to severe fear, stress, anxiety and loss of enjoyment of life.
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Manufacturer Narrative
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As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, thrombosis and occlusion of the ivc below the filter, venous insufficiency, lower leg swelling, and venous stasis ulcers.Per the patient profile form (ppf), the device was implanted due to left leg deep vein thrombosis.There were no reported immediate complications.The patient reports perforation of filter struts outside the ivc and perforation of filter struts into organs, blood clots, clotting and or occlusion of the ivc, device unable to be retrieved, le edema, collateral veins, venous stasis, legs black.The patient symptom and injuries include, but are not limited to ivc thrombosis, occlusion of the ivc, severe leg swelling, leg pain, anxiety, irretrievability of the filter and perforation of the ivc with six (6) struts perforating the ivc between 3mm and 6mm.One perforated strut abuts the aortic wall and it is starting to extend into the aortic wall.There has been no retrieval attempt, information or details provided.Approximately ten years and eight months after implant, a ct scan revealed that the filter appears structurally intact with no significant tilt of the long axis of the ivc.The apex of the filter is about 2cm below the renal vein inflow.No evidence of any embolized filter fragment into the heart or lungs or elsewhere into the upper abdomen.There is penetration of all six (6) legs beyond the wall of the vena cava between 3 and 6 mm.On the axial images, the leg of the filter abuts the aortic wall and may be starting to extend into the aortic wall.Additionally, the ct demonstrated lung nodules, atelectasis and superficial to chest and abdominal wall venous collaterals, suggesting venous obstruction.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 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.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, venous obstruction and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Venous insufficiency, swelling of legs, venous ulcer, collateral circulation, skin discoloration, pain legs, and anxiety do 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.
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Event Description
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As reported in the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, thrombosis and occlusion of the ivc below the filter, venous insufficiency, lower leg swelling, and venous stasis ulcers.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 following additional information received per the patient profile form (ppf) indicates the device was implanted due to left leg deep vein thrombosis.The patient was reported to have tolerated the index procedure well.The patient is reported to have experienced the device being embedded in the ivc, collateral veins, discoloration of the legs, pain in the legs, and is reported to continue to experience anxiety related to the device.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately seven years and four months post implantation.The patient reports blood clots, clotting and or occlusion of the inferior vena cava (ivc), device unable to be retrieved, leg (le) edema, collateral veins, venous stasis, legs black.The patient symptom and injuries include, but are not limited to ivc thrombosis, severe leg swelling, leg pain and the ivc filter cannot be removed, although filter retrieval attempt details were not provided.The irretrievable filter also subjects the patient to the ongoing risk of deep vein thrombosis (dvt) and thrombosis of the lower body.The filter poses a progressive risk of perforation of the vena cava and surrounding vital organs, vessels and structures, which can result is severe pain and threatening complications.It also poses an increased and progressive risk of migration and fracture causing serious injury and death.The patient further reports living with the possibility that these complications can happen at any moment, which has led to severe fear, stress, anxiety and loss of enjoyment of life.Approximately ten years and eight months after the filter was implanted, the patient was submitted to an abdominal computerized tomography (ct) scan for evaluation of the ivc filter.The ct scan revealed that the filter appears to be structurally intact with no significant tilt of the long axis of the ivc.The apex of the filter is about 2cm below the renal vein inflow.No evidence of any embolized filter fragment into the heart or lungs or elsewhere into the upper abdomen.There is penetration of all six (6) legs beyond the wall of the vena cava between 3 and 6 mm.On the axial images, the leg of the filter abuts the aortic wall and may be starting to extend into the aortic wall.Additionally, the ct demonstrated lung nodules, atelectasis and superficial to chest and abdominal wall venous collaterals, suggesting venous obstruction.According to the information received in the redacted amended patient profile form (ppf2), the patient became aware of the reported events approximately seven years and four months post implantation.The patient reports perforation of filter struts outside the ivc and perforation of filter struts into organs, blood clots, clotting and or occlusion of the ivc, device unable to be retrieved, le edema, collateral veins, venous stasis, legs black.The irretrievable filter also subjects the patient to the risk of future and progressive filter failure, including migration, fracture, embolization of a fracture, perforation, thrombosis and even death.The patient symptom and injuries include, but are not limited to ivc thrombosis, occlusion of the ivc, severe leg swelling, leg pain, irretrievability of the filter and perforation of the ivc with six (6) struts perforating the ivc between 3mm and 6mm.One perforated strut abuts the aortic wall and it is starting to extend into the aortic wall.There has been no retrieval attempt, information or details provided.The filter poses a progressive risk of additional perforation of the vena cava and surrounding vital organs, vessels and structures, which can result in severe pain and life-threatening complications.It also poses and ongoing risk of worsening occlusion/clotting/thrombosis, migration, fracture and embolization of a fracture causing serious injury and death.The patient further reports living with the possibility that these complications can happen at any moment, which has led to severe fear, stress, anxiety and loss of enjoyment of life.
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