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| Catalog Number 466P306AU |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Death (1802); Hematoma (1884); Hypovolemic Shock (1917); Occlusion (1984); Perforation (2001); Vascular Dissection (3160)
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| Event Date 02/20/2015 |
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Event Type
Death
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Manufacturer Narrative
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(b)(4).A review of the manufacturing documentation associated with this lot 15622584 presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.
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Event Description
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As reported by the legal brief, as a result of the device's defects and defendants tortious acts/omissions, the patient, and many other patients who received these devices, endured unnecessary pain and suffering; debilitating lack of mobility; and subsequent surgeries to replace the faulty device and address complications arising from the device, giving rise to more pain and suffering, a prolonged recovery time, and an increased risk of complications and death.Additional information received indicated that the patient also experienced perforation and an acute inferior vena cava dissection.
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Manufacturer Narrative
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As reported, a patient had a trapease inferior vena cava filter implanted in (b)(6) 2012.On or about three years and five months later, the patient experienced perforation of the vena cava and an acute inferior vena cava dissection leading to his death, as noted in the autopsy report.The patient endured unnecessary pain and suffering; debilitating lack of mobility; and subsequent surgeries to replace the faulty device and address complications arising from the device, giving rise to more pain and suffering, a prolonged recovery time, and an increased risk of complications and death.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.An 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.The legal briefing mentioned a perforation of the ivc wall.Without procedural films available for review, the reported perforation could not be confirmed.With the information available it is not possible to draw a clinical conclusion to the reported event, and the exact cause could not be determined.It is well known that perforation of a vessel may possibly lead to dissection of that vessel.Dissection of a large vessel, such as the ivc, is likely to lead to death if medical treatment is not successful.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.With the limited information available for review at this time, 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.
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Event Description
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Additional information received per the medical records indicate that the patient has a history of inguinal hernia repair, hypertension, gastroesophageal reflux disease (gerd), osteoarthritis and benign prostatic hyperplasia (bph).Approximately one week prior to implantation the patient was admitted with a recent history of deep vein thrombosis (dvt) while on coumadin, dizziness and headache.A computed tomography (ct) scan diagnosed an intracranial bleed.The indication for filter placement was factor v leiden, with right frontal intraparenchymal cerebral hemorrhage and right leg dvt.A venocavogram located the renal veins and assessed the caliber of the inferior vena cava (ivc).The filter was successfully deployed in an infrarenal position.There were no reports of complications.Approximately three years and five months after the index procedure, the patient was seen in the emergency room (er) for lightheadedness.The patient was diagnosed with dehydration and orthostatic hypotension.Fluids were given and the patient was discharged home.The next day emergency medical services (ems) was called and the patient was transported as a trauma secondary to a fall.The patient was hypotensive and unresponsive.The patient was intubated by ems and transported to the er.The patient remained unresponsive, bloody rectal exam was noted.Pulseless electrical activity (pea/cardiac arrest) occurred in er, the patient was unresponsive to resuscitation efforts and was pronounced dead.Additional information received per the final autopsy report states that the cause of death was related to hypovolemic shock, massive retroperitoneal hematoma, associated with an acute inferior vena cava dissection/rupture.The filter contained a thrombus, causing complete occlusion of the filter.There was evidence of a small chronic inferior vena cava (ivc) dissection prior to the acute event leading to the death.Incidental findings include mild atherosclerotic heart disease, fatty liver, diverticula of the colon and cerebrovascular disease.Included in the report were images of the dissection of the internal organs including, but not limited to the brain, lungs, heart, ivc, intestines and liver.The dissection of the abdomen and ivc were noted.A cordis type filter was visualized in the ivc and appeared to be destructed by the dissection.A large amount of blood was noted within the abdominal cavity.The reviewer of this report was unable to visualize any damage to the ivc prior to the dissection of the filter by the medical examiner.Two radiographic images were presented.A cordis type vena cava filter was visualized in a disarticulated segment of what was presumably the vena cava after removal during autopsy.
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Manufacturer Narrative
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Section h6: health effect: clinical code: code 1884 was used for 'retroperitoneal hematoma'.Additional information is pending and will be submitted within 30 days of receipt.
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Manufacturer Narrative
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After further review of additional information received, the following sections have as reported, the patient had a trapease inferior vena cava (ivc) filter implanted.Per the medical records, history includes inguinal hernia repair, hypertension, gastroesophageal reflux disease (gerd), osteoarthritis and benign prostatic hyperplasia (bph).Approximately one week prior to implantation the patient was admitted with a recent history of deep vein thrombosis (dvt) while on coumadin, dizziness and headache.The indication for filter placement was factor v leiden, with right frontal intraparenchymal cerebral hemorrhage and right leg dvt.A venocavogram located the renal veins and assessed the caliber of the ivc.The filter was successfully deployed in an infrarenal position.There were no reports of complications.Approximately three years and five months after implant, the patient was seen in the emergency room (er) for lightheadedness, diagnosed with dehydration and orthostatic hypotension.Fluids were given and the patient was discharged home.The next day, the patient fell at home and was transported via emergency medical services (ems) as a trauma secondary to a fall.The patient was hypotensive and unresponsive at his home.The patient was intubated by ems and transported to the er.The patient remained unresponsive, bloody rectal exam was noted.Pulseless electrical activity (pea/cardiac arrest) occurred in er, resuscitation efforts were unsuccessful, and the patient was pronounced dead.Per the final autopsy report, the cause of death was related to hypovolemic shock, massive retroperitoneal hematoma, associated with an acute inferior vena cava dissection/rupture.During the dissection, the filter was noted to contain a thrombus, causing complete occlusion of the filter.There was evidence of a small chronic ivc dissection prior to the acute event leading to the death.Incidental findings include mild atherosclerotic heart disease, fatty liver, diverticula of the colon and cerebrovascular disease.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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 and dissection are known potential adverse events associated to the use of all ivc filters.Some degree of perforation 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.However, catastrophic perforation/dissection has also been reported.Hypovolemic shock and retroperitoneal hematoma are expected sequalae secondary to the ivc perforation/dissection, and may result in death, as in this case.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 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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It was reported that a patient had a trapease inferior vena cava filter implanted.Approximately three years and five months later, the patient experienced perforation of the vena cava and an acute inferior vena cava dissection leading to his death, as noted in the autopsy report.According to the medical records, the patient had a history of inguinal hernia repair, hypertension, gastroesophageal reflux disease (gerd), osteoarthritis and benign prostatic hyperplasia (bph).Approximately one week prior to the implant the patient was admitted with a recent history of deep vein thrombosis (dvt) while on coumadin, dizziness and headache.A computed tomography (ct) scan diagnosed an intracranial bleed.The indication for filter placement was factor v leiden, with right frontal intraparenchymal cerebral hemorrhage and right leg dvt.A venocavogram located the renal veins and assessed the caliber of the inferior vena cava (ivc).The filter was successfully deployed in an infrarenal position.There were no reports of complications.Five months after the filter was implanted the patient underwent removal of a skin tag.Approximately twenty months post implant, the patient underwent surgical intervention for benign prostatic hypertrophy (bph).Approximately two years and three months post implant, a lumbar magnetic resonance imaging (mri) was indicated for back pain which the patient had developed after pushing a snow blower.The mri scan revealed l1-2 through l5-s1 foraminal encroachment with facet joint hypertrophy, bulging annulus and indentation of the thecal sac, representing degenerative changes and spinal stenosis of the lumbar spine.About a month later, the patient had a neurosurgical consultation regarding right leg pain associated to degenerative scoliosis and was then seen six times for right buttock pain and diagnosed with lumbar stenosis, degenerative disk disease and radiculopathy.This was treated with epidural injections for pain control.A history of transient ischemic attack (tia), cerebral hemorrhage, hypertension, hypercholesterolemia, ulcers, hepatitis, benign prostatic hypertrophy, right leg dvt and filter placed for dvt was noted at the time.Approximately three years and five months post implant the patient was seen in the emergency room (er) for lightheadedness.The patient was diagnosed with dehydration and orthostatic hypotension, treated with fluids and discharged home.The following day emergency medical services (ems) was called, and the patient was transported as a trauma secondary to a fall.The patient was hypotensive and unresponsive.The patient was intubated by ems and transported to the er.The patient remained unresponsive, bloody rectal exam was noted.Pulseless electrical activity (pea/cardiac arrest) occurred in the er, the patient was unresponsive to resuscitation efforts and was pronounced dead.The final autopsy report stated that the cause of death was related to hypovolemic shock, massive retroperitoneal hematoma, associated with an acute inferior vena cava dissection/rupture.The filter contained a thrombus, causing complete occlusion of the filter.There was evidence of a small chronic inferior vena cava (ivc) dissection prior to the acute event leading to the death.Incidental findings include mild atherosclerotic heart disease, fatty liver, diverticula of the colon and cerebrovascular disease.Included in the report were images of the dissection of the internal organs including, but not limited to the brain, lungs, heart, ivc, intestines and liver.The dissection of the abdomen and ivc were noted.A cordis type filter was visualized in the ivc and appeared to be destructed by the dissection.A large amount of blood was noted within the abdominal cavity.The reviewer of this report was unable to visualize any damage to the ivc prior to the dissection of the filter by the medical examiner.Two radiographic images were presented.A cordis type vena cava filter was visualized in a disarticulated segment of what was presumably the vena cava after removal during autopsy.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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 and dissection are known potential adverse events associated to the use of all ivc filters.Some degree of perforation 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.However, catastrophic perforation/dissection has also been reported.Hypovolemic shock and retroperitoneal hematoma are expected sequalae secondary to the ivc perforation/dissection, and may result in death, as in this case.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics, such as a chronic dissection of the ivc.Given the 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 by the legal brief, a patient had a trapease inferior vena cava filter implanted.On or about three years and five months later, the patient experienced perforation of the vena cava and an acute inferior vena cava dissection leading to his death, as noted in the autopsy report.The patient endured unnecessary pain and suffering; debilitating lack of mobility; and subsequent surgeries to replace the faulty device and address complications arising from the device, giving rise to more pain and suffering, a prolonged recovery time, and an increased risk of complications and death.Additional information received per the medical records indicate that the patient had a history of inguinal hernia repair, hypertension, gastroesophageal reflux disease (gerd), osteoarthritis and benign prostatic hyperplasia (bph).Approximately one week prior to implantation the patient was admitted with a recent history of deep vein thrombosis (dvt) while on coumadin, dizziness and headache.A computed tomography (ct) scan diagnosed an intracranial bleed.The indication for filter placement was factor v leiden, with right frontal intraparenchymal cerebral hemorrhage and right leg dvt.A venocavogram located the renal veins and assessed the caliber of the inferior vena cava (ivc).The filter was successfully deployed in an infrarenal position.There were no reports of complications.Five months after the filter was implanted the patient underwent removal of a skin tag.About a year and eight months after the filter was implanted, the patient underwent surgical intervention for benign prostatic hypertrophy (bph).Approximately two years and three months after the filter was implanted, a lumbar magnetic resonance imaging (mri) was indicated for back pain which the patient had developed after pushing a snow blower.The mri scan revealed l1-2 through l5-s1 foraminal encroachment with facet joint hypertrophy, bulging annulus and indentation of the thecal sac, representing degenerative changes and spinal stenosis of the lumbar spine.About a month later, the patient had a neurosurgical consultation regarding right leg pain associated to degenerative scoliosis and was then seen six times for right buttock pain and diagnosed with lumbar stenosis, degenerative disk disease and radiculopathy.This was treated with epidural injections for pain control.A history of transient ischemic attack (tia), cerebral hemorrhage, hypertension, hypercholesterolemia, ulcers, hepatitis, benign prostatic hypertrophy, right leg dvt and filter placed for dvt was noted at the time.Approximately three years and five months after the index procedure, the patient was seen in the emergency room (er) for lightheadedness.The patient was diagnosed with dehydration and orthostatic hypotension.Fluids were given and the patient was discharged home.The next day emergency medical services (ems) was called, and the patient was transported as a trauma secondary to a fall.The patient was hypotensive and unresponsive.The patient was intubated by ems and transported to the er.The patient remained unresponsive, bloody rectal exam was noted.Pulseless electrical activity (pea/cardiac arrest) occurred in er, the patient was unresponsive to resuscitation efforts and was pronounced dead.Additional information received per the final autopsy report states that the cause of death was related to hypovolemic shock, massive retroperitoneal hematoma, associated with an acute inferior vena cava dissection/rupture.The filter contained a thrombus, causing complete occlusion of the filter.There was evidence of a small chronic inferior vena cava (ivc) dissection prior to the acute event leading to the death.Incidental findings include mild atherosclerotic heart disease, fatty liver, diverticula of the colon and cerebrovascular disease.Included in the report were images of the dissection of the internal organs including, but not limited to the brain, lungs, heart, ivc, intestines and liver.The dissection of the abdomen and ivc were noted.A cordis type filter was visualized in the ivc and appeared to be destructed by the dissection.A large amount of blood was noted within the abdominal cavity.The reviewer of this report was unable to visualize any damage to the ivc prior to the dissection of the filter by the medical examiner.Two radiographic images were presented.A cordis type vena cava filter was visualized in a disarticulated segment of what was presumably the vena cava after removal during autopsy.
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Search Alerts/Recalls
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