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| Catalog Number 466P306AU |
| Device Problems
Fracture (1260); Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
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| Patient Problems
Pulmonary Embolism (1498); Erosion (1750); Death (1802); Hematoma (1884); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Perforation (2001); Thrombosis (2100); Vascular System (Circulation), Impaired (2572); Blood Loss (2597)
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| Event Date 04/02/2016 |
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Event Type
Death
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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.Approximately 11 years and 9 months, the filter subsequently malfunctioned and caused great bodily harm to the patient, including, but not limited to, perforation of the filter through the inferior vena cava, directly and proximately causing internal hemorrhaging and death.As a direct and proximate results of these filter malfunctions, the patient suffered fatal injuries, damages, and untimely death.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 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 brief reported perforation of the ivc and internal hemorrhage; 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 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.Internal hemorrhage does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.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.Approximately 11 years and 9 months, the filter subsequently malfunctioned and caused great bodily harm to the patient, including, but not limited to, perforation of the filter through the inferior vena cava, directly and proximately causing internal hemorrhaging and death.As a direct and proximate results of these filter malfunctions, the patient suffered fatal injuries, damages, and untimely death.
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Manufacturer Narrative
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The following additional information received per the patient profile from (ppf) indicates that the filter perforated into the organs, the filter and the filter¿s fractured struts migrated and that the filter was tilted.The filter is reported to have been removed during the autopsy by the medical examiner.The autopsy report is not available, however, per the ppf the patient¿s death was due to filter erosion in the vena cava.Prior to this, the patient had presented to the hospital complaining of leg pain, tightness and swelling.It was reported that a patient underwent placement of a trapease vena cava filter.Approximately eleven years and nine months post implantation, the filter subsequently malfunctioned and caused great bodily harm to the patient, including, but not limited to perforation of the filter through the inferior vena cava (ivc), directly and proximately causing internal hemorrhaging and death.The following additional information received per the patient profile from (ppf) indicates that the filter perforated into the organs, the filter and the filter¿s fractured struts migrated and that the filter was tilted.The filter is reported to have been removed during the autopsy by the medical examiner.The autopsy report is not available, however, per the ppf the patient¿s death was due to filter erosion in the vena cava.Prior to this, the patient had presented to the hospital complaining of leg pain, tightness and swelling.The patient¿s medical history, the indication for the device implant has not been provided and there is currently no additional information available.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) review could be performed.Without procedural films for review, the reported filter tilt, fracture/separation, vena cava erosion and migration of the filter could not be confirmed and the exact cause could not be determined.The timing and mechanism of the tilt, fracture and migration are unknown at this time.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes 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.The documentation reported perforation of the ivc and internal hemorrhage; 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.Internal hemorrhage does not represent a device malfunction.Leg pain, tightness and swelling are not representative of a device malfunction and may be related to underlying patient specific issues.With the limited information currently available for review it is not possible to determine what factors may have contributed to those events and the death of the patient.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.
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Manufacturer Narrative
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The following additional information received per the patient profile from (ppf) indicates that the filter perforated into the organs, the filter and the filter¿s fractured struts migrated and that the filter was tilted.Also, as per the ppf, the patient¿s death was due to filter erosion in the vena cava.The filter is reported to have been removed during the autopsy by the medical examiner.The following additional information received per the medical records indicate that recurrent right femoral-popliteal deep vein thrombosis (dvt) as the indication for ivc filter placement.During ivc filter placement via the left common femoral vein, decision was made to place an infrarenal ivc filter just below the level of the lower right renal vein.This was deployed in the usual fashion in a perfect vertical alignment.Completion cavogram confirmed good position, no tortuosity, thrombosis, damage and continued flow in the renal veins.Approximately on or about four years, one month, and six days post implantation of filter, patient was seen general and vascular surgery physician for his leg edema and right ankle itch and ache.Patient was found to have grade iv chronic venous insufficiency due to likely outflow obstruction with an element of significant venous reflux disease.At the time of this visit, patient was found to not have an acute dvt.Patient was told to wear compression hose.According to the medical records, approximately on or about six years, three months, and seven days post implantation of ivc filter, patient continued to suffer from seizures despite new medications and was started on warfarin for multiple cerebral infarcts seen on mri without clear source.Approximately nine years and nine months post filter implantation, it was noted that patient stopped taking coumadin.Approximately eleven years, nine months and ten days post implantation of ivc filter, patient came to emergency room (er) with lower extremity discoloration, pain, tightness, and swelling.The tightness was noted to be greater on the left extremity than the right.The patient was noted to no longer be on anticoagulation.The patient had a remote history of dvt and cigarette smoking and was at the time using electronic cigarettes.The patient had also had an increased in seizures suffered in the last twenty-four hours and suffered two more seizures in the er.While in the er the patient had increased respiratory distressed and was treated for pulmonary embolism (pe) and dvt with tpa.Patient coded and became unresponsive to treatments and expired.According to the certificate of death the immediate cause of death was acute intra-abdominal hemorrhage due to or as a consequence of erosion of inferior vena cava in a person with an inferior vena caval filter.The certificate of death also states that other significant conditions contributing to death but not resulting in underlying cause are hypertensive and atherosclerotic cardiovascular disease and epilepsy.The medical examiner also found left retroperitoneal hematoma, hemoperitoneum, thrombosis of inferior vena cava filter, erosions of the inferior vena cava filter through inferior vena caval wall.Additional information is pending and will be submitted within 30 days upon receipt.
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Manufacturer Narrative
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After further review of additional information received.A film review was conducted on autopsy photographs received.There appeared to be an inferior vena cava (ivc) filter in place with a large thrombus within the filter.At least one of the filter struts extended beyond the ivc wall.Several of the filter struts were tenting the ivc wall.No images from the initial filter placement or imaging studies from the er visit are available for review.Additional information is pending and will be submitted within 30 days upon receipt.
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Manufacturer Narrative
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It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that approximately eleven years and nine months post implant, the filter subsequently malfunctioned and caused great bodily harm to the patient, including, but not limited to perforation of the filter through the inferior vena cava (ivc), directly and proximately causing internal hemorrhaging and death.The following additional information received per the patient profile form (ppf) indicated that the filter perforated into the organs, the filter and the filter¿s fractured struts migrated and that the filter was tilted.The information received also indicated that the patient experienced venous insufficiency with pain, swelling and skin tightness and discoloration.The indication for the filter implant was a history of recurrent right femoral-popliteal deep vein thrombosis (dvt).The patient¿s other medical history consisted of a seizure disorder since the age of four, treated with multiple medications, deep venous thrombosis in the lower leg up to the popliteal fossa, four years prior to the filter implant, treated with heparin and coumadin, elevated homocysteine levels, behavioral issues, probably secondary to keppra and remote history of tobacco use, the patient also had a vagal nerve stimulator implanted at some point after the filter was implanted.The filter was placed via the left common femoral vein and deployed just below the level of the right renal vein.During placement a left femoral iliac cavogram performed.This study identified a widely patent iliofemoral system with free flow into the cava at the l4-5 level.Following this, an 0.035 movable core wire was placed at the l1 level and the 6 french trapeze filter introducer switched out for the 5 french introducer at the l4 level.An ap cavogram was performed through the 6 french introducer confirming a widely patent left renal vein at the l1-2 interspace but could not visualize the right renal vein.Therefore the introducer was removed and through the sheath a c2 diagnostic catheter placed.This was used to hook and selectively study the right renal vein.This was at the l1-2 interspace, slightly lower than the left.There was evidence of vessel wall irregularity possibly due to prior phlebitis but this was patent at this time.The cava measured 22 mm in diameter.The decision was made to place an infrarenal ivc filter just below the level of the lower right renal vein.This was deployed in the usual fashion in a perfect vertical alignment.Completion cavogram confirmed good position, no tortuosity, thrombosis, damage and continued flow in the renal veins.Approximately four years post implant of the filter, the patient was seen by a general and vascular physician for his leg edema and right ankle itch and ache.Patient was found to have grade iv chronic venous insufficiency due to likely outflow obstruction with an element of significant venous reflux disease.At the time of this visit, patient was found to not have an acute dvt.Patient was told to wear compression hose.According to the medical records, approximately on or about six years, three months, and seven days post implantation of ivc filter, patient continued to suffer from seizures despite new medications and was started on warfarin for multiple cerebral infarcts seen on mri without a clear source.Approximately nine years and nine months post filter implantation, it was noted that patient stopped taking coumadin.Approximately eleven years, nine months and ten days post implantation of ivc filter, patient came to emergency room (er) with lower extremity discoloration, pain, tightness, and swelling.The initial assessment of the patient noted general appearance of mild distress, no respiratory distress, with equal and clear bilateral breath sounds, tachycardia was noted.The tightness was noted to be greater on the left extremity than the right.The patient was noted to no longer be on anticoagulation.The patient had also had an increase in seizures suffered in the last twenty-four hours and suffered two more seizures in the er.After the last seizure the patient was given a dose of lorazepam and the post-ictal phase was of moderate somnolence, shortly thereafter, the patient unresponsive and hypoxic.Upon assessment, pulses were present, respirations were agonal, the patient quickly became pulseless and cpr was initiated.Spontaneous respirations and a pulse were regained, however, did not last and cpr was restarted and the patient was intubated.The patient and was treated for pulmonary embolism (pe) and dvt with tissue plasminogen activator (tpa).Chest compressions were performed for thirty minutes but the patient remained in cardiac standstill, all resuscitative measures were terminated.The case was discussed with the medical examiners office and an autopsy was performed.According to the certificate of death the immediate cause of death was acute intra-abdominal hemorrhage due to or as a consequence of erosion of inferior vena cava in a person with a inferior vena caval filter.The certificate of death also states that other significant conditions contributing to death but not resulting in underlying cause are hypertensive and atherosclerotic cardiovascular disease and epilepsy.The medical examiner also found left retroperitoneal hematoma, hemoperitoneum, thrombosis of inferior vena cava filter, erosions of the inferior vena cava filter through inferior vena caval wall.The filter is reported to have been removed during the autopsy by the medical examiner.Imaging provided by the medical examiner have been sent to independent physician for review.The product was not returned for analysis.The dhr could not be completed.The trapease 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 timing and mechanism of the tilt, fracture,perforation and migration are unknown at this time.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes 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.The documentation reported perforation of the ivc and internal hemorrhage; 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.With the information provided, it is not possible to confirm or clarify erosion of the ivc wall.Pe is a known complication associated with ivc filters and is listed as such in the ifu.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Leg pain, tightness, skin discoloration, chronic venous insufficiency and swelling are not representative of a device malfunction and may be related to underlying patient specific issues.The summary from the independent reviewer of the images provided from by the medical examiner.¿five autopsy specimen photographs of the ivc are submitted for review.There appears to be an ivc filter in place with a large thrombus within the filter.At least one of the filter struts extends beyond the ivc wall.Several of the struts are tenting the ivc wall.No images from the initial filter placement or imaging studies from the er visit are available for review.The death certificate is provided listing the primary cause of death as acute intra-abdominal hemorrhage.The information provided is too limited to derive any conclusions regarding the cause of death.¿ hemorrhage is a potential complication associated with administering tissue plasminogen activator.With the limited information currently available for review it is not possible to determine what factors may have contributed to those events and the death of the patient.There is nothing in the information provided 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 a trapease vena cava filter.Approximately eleven years and nine months post implantation, the filter subsequently malfunctioned and caused great bodily harm to the patient, including, but not limited to perforation of the filter through the inferior vena cava (ivc), directly and proximately causing internal hemorrhaging and death.The following additional information received per the patient profile from (ppf) indicates that the filter perforated into the organs, the filter and the filter¿s fractured struts migrated and that the filter was tilted.Also, as per the ppf, the patient¿s death was due to filter erosion in the vena cava.The filter is reported to have been removed during the autopsy by the medical examiner.The following additional information received per the medical records indicate that recurrent right femoral-popliteal deep vein thrombosis (dvt) as the indication for ivc filter placement.During ivc filter placement via the left common femoral vein, decision was made to place an infrarenal ivc filter just below the level of the lower right renal vein.This was deployed in the usual fashion in a perfect vertical alignment.Completion cavogram confirmed good position, no tortuosity, thrombosis, damage and continued flow in the renal veins.Approximately on or about four years, one month, and six days post implantation of filter, patient was seen general and vascular surgery physician for his leg edema and right ankle itch and ache.Patient was found to have grade iv chronic venous insufficiency due to likely outflow obstruction with an element of significant venous reflux disease.At the time of this visit, patient was found to not have an acute dvt.Patient was told to wear compression hose.According to the medical records, approximately on or about six years, three months, and seven days post implantation of ivc filter, patient continued to suffer from seizures despite new medications and was started on warfarin for multiple cerebral infarcts seen on mri without clear source.Approximately nine years and nine months post filter implantation, it was noted that patient stopped taking coumadin.Approximately eleven years, nine months and ten days post implantation of ivc filter, patient came to emergency room (er) with lower extremity discoloration, pain, tightness, and swelling.The tightness was noted to be greater on the left extremity than the right.The patient was noted to no longer be on anticoagulation.The patient had a remote history of dvt and cigarette smoking and was at the time using electronic cigarettes.The patient had also had an increased in seizures suffered in the last twenty-four hours and suffered two more seizures in the er.While in the er the patient had increased respiratory distressed and was treated for pulmonary embolism (pe) and dvt with tpa.Patient coded and became unresponsive to treatments and expired.According to the certificate of death the immediate cause of death was acute intra-abdominal hemorrhage due to or as a consequence of erosion of inferior vena cava in a person with an inferior vena caval filter.The certificate of death also states that other significant conditions contributing to death but not resulting in underlying cause are hypertensive and atherosclerotic cardiovascular disease and epilepsy.The medical examiner also found left retroperitoneal hematoma, hemoperitoneum, thrombosis of inferior vena cava filter, erosions of the inferior vena cava filter through inferior vena caval wall.According to the discovery form, the patient received the ivc filter for deep vein thrombosis (dvt).Medical conditions and treatments alleged to be attributable to the implanted ivc filter include acute intraabdominal hemorrhage due to erosion of the inferior vena cava filter resulting in death; thrombosis of the ivc filter through the inferior vena caval wall; erosions of the ivc filter through the inferior vena cava wall; progressive leg discoloration pain, tightness and swelling, and past emotional distress up to the point of death.
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Manufacturer Narrative
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As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, the indication for filter placement was recurrent right femoral-popliteal deep vein thrombosis (dvt).Medical history includes dvt and seizures.The ivc filter was deployed just below the level of the lower right renal vein.Completion venacavogram confirmed good position, no damage and continued flow in the renal veins.Approximately twelve years post implantation, the filter malfunctioned including, but not limited to, perforation of the filter through the inferior vena cava (ivc), causing internal hemorrhaging and death.Approximately four years post implant, patient had grade iv chronic venous insufficiency likely due to outflow obstruction with an element of significant venous reflux disease.At the time of this visit, patient did not have acute dvt.Approximately six years post implant, patient had seizures, and multiple cerebral infarcts on ct without clear etiology, despite new seizure medications.Warfarin was started at this time.Approximately ten years post implant, the patient stopped taking warfarin.Approximately twelve years post implant, the patient presented to the er with lower extremity discoloration, pain, tightness, and swelling.The tightness was noted to be greater on the left extremity than the right.The patient also had an increase in seizures in the previous twenty-four hours and suffered two seizures in the er.While in the er the patient was treated for pulmonary embolism (pe) and dvt with tpa.Patient coded, became unresponsive to treatments and expired.Per the death certificate, the immediate cause of death was acute intra-abdominal hemorrhage due to erosion of ivc by the ivc filter.Other contributing factors were hypertension, atherosclerotic cardiovascular disease and epilepsy.The medical examiner also found left retroperitoneal hematoma, hemoperitoneum, thrombosis of inferior vena cava filter, erosions of the filter through inferior vena caval wall.Per the patient profile from (ppf), the filter migrated, perforated into the organs, and was tilted.Further, the patient¿s death was due to filter erosion of the ivc.Prior to death, the patient suffered anxiety.The product was not returned for analysis.The dhr could not be completed.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.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 and surrounding structures; 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.The instructions for use (ifu) states filter fracture with separation is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Post procedure pulmonary embolism is a known potential adverse event associated with the use of the ivc filters.These events may be related to excessive clot burden from underlying patient specific factors.Retroperitoneal hematoma, internal hemorrhage, and medical device site erosion are all known potential events associated to the use of the cordis ivc filters.It is a known phenomenon associated to all device implantation, where the body will react to the presence of a foreign body by ¿pulling¿ away from the source of irritation (the device).In this instance there was perforation and erosion of the ivc vessel leading to the extensive bleeding that caused death.Pain and swelling of the legs, skin tightness, skin discoloration, and chronic venous insufficiency do not represent a device malfunction and may be related to underlying patient specific 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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