|
|
| Model Number 466P306AU |
| Device Problem
Defective Component (2292)
|
| Patient Problem
Occlusion (1984)
|
| Event Date 08/29/2008 |
|
Event Type
Injury
|
|
Event Description
|
|
As reported by 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, a ct scan of the patients abdomen showing blocking of his inferior vena cava.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, pain and suffering, and other damages.
|
| |
|
Manufacturer Narrative
|
|
It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to blocking of the inferior vena cava.A computed tomography scan performed at some point post implant showed blocking of the inferior vena cava.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, pain and suffering, and other damages.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 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.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 and result in edema of the extremity.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.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could not be confirmed.The source of the blockage in the ivc has not been provided.It is unknown if it is due to thrombus formation or stenosis of the vessel.Without images or the patient¿s medical history available to review it is not possible to establish a relationship between the reported events and the device.Given the limited information currently 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.
|
| |
|
Manufacturer Narrative
|
|
After further review of additional information received the following sections a2, a4, a5, b5, b7, g4, g7 and h2 have been updated according section b5: additional information received indicates that according to the medical record the patient was admitted to the hospital after an accident involving the farm tractor.The sustained a spinal vertebral fracture (fx) resulting in paraplegia with bowel and bladder dysfunction, in addition to multiple displaced left and right rib fractures.While in the hospital the patient experienced a hemothorax, paroxysmal supraventricular tachycardia, deep vein thrombosis and bilateral pulmonary embolism.The patient also developed vancomycin-resistant enterococci (vre) and methicillin-resistant staphylococcus aureus (mrsa).Approximately twenty-one days after admission an ivc filter was implanted for bilateral pe and the need for surgery and discontinuation of heparin therapy.Three days prior a computed tomography (ct) scan noted bilateral, right greater than left, pulmonary emboli (pe).The largest embolus extends from the right upper lobe pulmonary arterial system down into the right lower lobe system and is almost occlusive within the right lower lobe.Bilateral lower lobe atelectasis.An ultrasound also noted a right peroneal deep vein thrombosis (dvt).On 7/6/2007 the filter was placed via an existing picc line access site in the left arm and deployed below the level of the renal veins.A new 6 french dual lumen was cut to the appropriate length and placed over the guidewire and secured in place.Four days later the patient underwent a spinal fusion of t10-l4 and t12-l1 laminectomy.The hospital course was complicated by a left hemothorax and pneumonia.Prior to the filter implant, three days after admission, a ct of the abdomen noted abnormal appearance of to the para-aortic abdominal soft tissues, presumably hemorrhage associated with vertebral fx.An abnormal lobulated mass involving the left adrenal gland, sludge noted in the gallbladder, diffuse fatty infiltration of the liver.The patient was eventually discharged to a rehabilitation facility approximately one-month post admission.Approximately four years and eleven months post implant, (b)(6) 2012, a ct scan of the thoracic spine was performed due to noise on movement status post-surgery.Results of the scan noted postsurgical changes with fracture of the right paravertebral rod just above the level of the l2 pedicle screw, suspected loosening of the left t11 and t12 pedicle screws, degenerative changes, hiatal hernia, fatty liver (pre-existing), cholelithiasis (pre-existing).Approximately seven years and seven months (b)(6) 2015) post implant the patient seen in the emergency room (er) for back pain radiating to the abdomen.A computed tomography (ct) scan of the abdomen was performed and noted a moderate sized hilar hernia.The inferior vena cava (ivc) inferior to the filter is threadlike and appears to be occluded, there are multiple venous collaterals involving the anterior abdominal wall.The patient was diagnosed with a stable hernia and discharged to home.Approximately eight years post implant ((b)(6) 2015) the patient was admitted to the er with abdominal pain and fever a urinary tract infection (uti) was diagnosed.A ct scan of the abdomen was performed for diagnostic purposes and showed chronic arthritis bilateral hips, unchanged and a mass like configuration of the left adrenal gland (pre-existing).The remainder of the ct scan was within normal limits.Ivc filter is in place and from the level of the inferior margin of the ivc filter there is an extremely tiny sized chronically occluded inferior aspect of the ivc, common iliac and external iliac veins, common femoral veins and multiple collateral vessels in the abdominal wall.While in the hospital the patient seen by wound care nurse for ulcerations of the right great toe, right lateral malleolus, right heel, left heel and left foot.Pproximately one month later (dos (b)(6) 2015) the patient presented for evaluation of decreased appetite, nausea, fluid retention and abdominal pain.Ct scan of the abdomen noted a new proximal left femur fx, surgery not indicated, ivc filter with occlusion of the ivc with extensive collaterals, gallstones (pre-existing), enlargement of the left adrenal gland (pre-existing) and hiatal hernia.Abdominal pain determined to be from lovenox injections.Venous duplex ultrasound- acute dvt of left common femoral vein, discharged on (b)(6) 2015 with home health.Ct images were provided, the images depict a device that is similar in shape to a cordis device, no further information can be gleaned from the images.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical record, the indication was dvt and pe after farming equipment induced trauma leading to a spinal cord injury, multiple fractures and extended bedrest complicated by infections.Approximately 18 days post trauma, a ct revealed bilateral pulmonary emboli (pe) and ultrasound noted deep vein thrombosis (dvt).Three days later, the filter was deployed below the renal veins.There were no reports of complications.The patient subsequently underwent a spinal fusion of t10-l4 and t12-l1.The filter subsequently malfunctioned including, but not limited to, ivc occlusion.Approximately 7.5 years post implant, a ct scan noted a moderate sized hilar hernia.The ivc inferior to the filter is threadlike and appeared to be occluded, with multiple venous collaterals involving the anterior abdominal wall.Approximately eight years post implant, the patient was seen for abdominal pain and fever, diagnosed as a urinary tract infection (uti).A ct scan ivc filter is in place and from the level of the inferior margin of the ivc filter there is an extremely tiny sized chronically occluded inferior aspect of the ivc, common iliac and external iliac veins, common femoral veins and multiple collateral vessels in the abdominal wall.While in the hospital, the patient seen for ulcerations of the right great toe, right lateral malleolus, right heel, left heel and left foot.Approximately one month later, the patient presented with decreased appetite, nausea, fluid retention and abdominal pain.Ct scan of the abdomen noted a new proximal left femur fx, surgery not indicated, ivc filter with occlusion of the ivc with extensive collaterals, gallstones (pre-existing), enlargement of the left adrenal gland (pre-existing) and hiatal hernia.Venous duplex ultrasound revealed acute dvt of left common femoral vein.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, including the distal ivc do not represent a device malfunction.Pain 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.
|
| |
|
Event Description
|
|
Additional information received per the medical records indicate that nineteen days prior to the index procedure the patient had a noted history of dyslipidemia and gastroesophageal reflux disease (gerd).Thoracolumbar spine injury with a need for surgical spinal stabilization.Injuries also included tension pneumothorax.Non-sustained ventricular tachycardia was also noted upon hospitalization. seven months after the index procedure lumbar spine imaging shows posterior rod fixation of the patient¿s thoracolumbar spine.(b)(6) 2008 approximately ten months after the index procedure, doppler ultrasound imaging of the lower extremities showed extensive bilateral lower deep vein thrombosis (dvt). the results of abdominal and pelvic computed tomography (ct) scans done one year and two months after the index procedure indicate that the patient experienced chronic thrombosis, scarring of proximal (to the filter) inferior vena cava (ivc) and chronic bilateral iliac thrombosis.The ivc above the filter was widely patent.There were also multiple abdominal varicose veins.
|
| |
|
Manufacturer Narrative
|
|
Additional information is pending and will be submitted within 30 days of receipt.Section e1 initial reporter name and address: address corrected.
.
|
| |
|
Manufacturer Narrative
|
|
As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of dyslipidemia and gastroesophageal reflux disease (gerd); along with trauma associated with a spinal cord injury, multiple fractures, pneumothorax and extended bedrest complicated by infections and paraplegia.Approximately eighteen months after the trauma, the patient developed bilateral pulmonary emboli (pe) and deep vein thrombosis (dvt).The patient was further noted to need further surgery.Three days later, the patient had a filter implanted in an infrarenal position without complications.The patient is further noted to have subsequently undergone planned spinal fusion of thoracic and lumbar vertebrae.Approximately ten months after the filter implantation, the patient developed extensive bilateral lower extremity dvts.Approximately eleven months after the filter implantation, the patient underwent a computerized tomography (ct) scan that revealed chronic thrombosis and scarring of the inferior vena cava (ivc) proximal to the filter, chronic bilateral iliac thrombosis and multiple abdominal varicose veins.The ivc above the filer was noted to be widely patent.Approximately seven and a half years after the filter implantation, the patient underwent a ct scan that revealed that the ivc was occluded below the filter and noted multiple venous collaterals involving the anterior of the abdominal wall.Approximately eight years after the filter implantation, the patient experienced abdominal pain.A ct scan revealed an extremely tiny, chronically occluded ivc below the level of the filter extending to the common iliac, external iliac and common femoral veins.There were multiple collateral vessels in the abdominal wall while hospitalized.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 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.Without procedural films for review, the reported ivc scarring and varicose veins could not be confirmed and the exact cause could not be determined.Stenosis, blood clots, clotting, embolism, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.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.
|
| |
|
Manufacturer Narrative
|
|
After further review of additional information received, the following sections have been updated accordingly: b4, b5,g3, g6, h1, h2 and h6.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, ivc and vasculature do not represent a device malfunction.Abdominal pain, scarring and varicose veins do not represent device malfunctions.However, they may be related to the underlying reported filter issue of occlusion.Secondary vessels will adapt to fulfill the need for venous return to the heart and may contribute to the varicose veins and abdominal pain.The scarring of the ivc may have contributed to the occlusion and be related to the body¿s response to a foreign object, in this case the attempt to react to the filter may have contributed to overgrowth of scar tissue in the ivc.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.
|
| |
|
Event Description
|
|
Additional information received per the medical records indicate that the patient has a history of diabetes.Seven months after the index procedure the patient experienced increasing edema of the left leg, secondary to tractor accident and paraplegia.The patient had skilled nursing care for ongoing chronic leg wounds approximately eight years and ten years after the accident.
|
| |
|
Manufacturer Narrative
|
|
As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical record, the indication was multiple trauma secondary to a tractor rollover accident, including spinal fracture with total cord disruption, and multiple displaced left and right rib fractures.Spinal reconstruction was done for stabilization; however, paraplegia resulting from the accident did not improve.Medical history at that time included diabetes, "gurd" and dyslipidemia.The patient developed deep vein thrombosis (dvt) leading to pulmonary emboli (pe) while in hospital.It is noted that the hospital course was protracted and complicated by (but not limited to) infection, arrythmia, and hemothorax.Approximately twenty-one days after admit, a venocavogram (done through the existing picc) 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.The patient was eventually discharged to rehab approximately one-month post admission.The filter subsequently malfunctioned including ivc occlusion.Approximately ten months post implant, doppler ultrasound imaging of the lower extremities showed extensive bilateral lower deep vein thrombosis (dvt).Approximately 14 months post implant, a ct scan revealed chronic thrombosis, scarring of proximal (to the filter) inferior vena cava (ivc) and chronic bilateral iliac thrombosis.The ivc above the filter was widely patent with multiple abdominal varicose veins.Approximately five years post implant, a ct noted postsurgical changes in the spinal hardware, degenerative changes in the spine, hiatal hernia, fatty liver and cholelithiasis.Approximately 7.5 years post implant, a ct scan noted a moderate sized hilar hernia, the ivc inferior to the filter was threadlike and appears occluded, with multiple venous collaterals involving the anterior abdominal wall.Approximately eight years post implant, the patient had abdominal pain and uti.A ct revealed chronic arthritis of the bilateral hips, unchanged, and a pre-existing adrenal mass.Ivc filter is in place and from the level of the inferior margin of the ivc filter there is an extremely tiny sized chronically occluded inferior aspect of the ivc, common iliac and external iliac veins, common femoral veins and multiple collateral vessels in the abdominal wall.Also noted were chronic wounds of the right great toe, right lateral malleolus, right heel, left heel and left foot.Approximately 8 years and 1 month post implant, the patient had decreased appetite, nausea, fluid retention and abdominal pain.Ct scan noted a new proximal left femur fx, and the ivc filter with occlusion of the ivc with extensive collaterals.A venous duplex ultrasound revealed acute dvt of left common femoral vein.Approximately 9 years post implant, ongoing skilled nursing visits were done to treat the chronic leg ulcers.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, ivc and vasculature do not represent a device malfunction.Abdominal pain, scarring and varicose veins do not represent device malfunctions; however, they may be related to the underlying reported filter issue of occlusion.Secondary vessels will adapt to fulfill the need for venous return to the heart and may contribute to the varicose veins and abdominal pain.The scarring of the ivc may have contributed to the occlusion and be related to the body¿s response to a foreign object, in this case the attempt to react to the filter may have contributed to overgrowth of scar tissue in the ivc.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.
|
| |
|
Manufacturer Narrative
|
|
As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.The filter malfunctioned and caused injury including ivc occlusion.Per the medical records, the indication was trauma from a farm tractor accident, resulting in spinal vertebral fractures (fx), paraplegia with bowel and bladder dysfunction, in addition to multiple displaced left and right rib fractures.While in the hospital the patient experienced hemothorax, paroxysmal supraventricular tachycardia, non-sustained ventricular tachycardia, deep vein thrombosis (dvt) and bilateral pulmonary embolism (pe).Medical history at this time includes gerd and dyslipidemia.The patient also developed drug resistant infections of vre and mrsa.Prior to the filter implant, a ct noted an abdominal hemorrhage associated with vertebral fracture.Also noted were a left adrenal gland lobulated mass involving the left adrenal gland, gallbladder sludge and diffuse fatty infiltration of the liver.Approximately twenty-one days after admission, an ultrasound also noted a right peroneal deep vein thrombosis (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.Four days later the patient underwent a spinal fusion of t10-l4 and t12-l1 laminectomy.The patient was eventually discharged to a rehabilitation facility approximately one-month post admission.Seven months after implant, imaging shows posterior rod fixation of the thoracolumbar spine.Three weeks after this imaging, the patient had increasing edema of the left leg.Approximately ten months after implant, imaging showed extensive bilateral lower dvt, with ivc filter obstruction and mild chronic leg swelling.Anticoagulation regimen was initiated and adjusted.Approximately one year after implant, ct imaging showed chronic thrombosis of and scarring of the ivc proximal to the filter, along with chronic bilateral iliac thrombosis.The ivc above the filter was widely patent.There were also multiple abdominal varicose veins.Ongoing medication regimen adjustments were noted.Approximately four years and eleven months post implant, a ct scan noted postsurgical changes with fracture of the right paravertebral rod just above the level of the l2 pedicle screw, suspected loosening of the left t11 and t12 pedicle screws, degenerative changes, hiatal hernia, fatty liver (pre-existing), cholelithiasis (pre-existing).Approximately seven years and seven months post implant, the patient had back pain radiating to the abdomen.A ct scan showed a moderate sized hilar hernia.The ivc inferior to the filter was threadlike and appeared to be occluded, with multiple venous collaterals involving the anterior abdominal wall.Approximately eight years post implant, the patient had abdominal pain and fever, and was diagnosed with a urinary tract infection (uti).A ct scan showed chronic arthritis bilateral hips, unchanged and a mass like configuration of the left adrenal gland (pre-existing).The ivc filter was in place.From the level of the inferior margin of the ivc filter there was an extremely tiny sized chronically occluded inferior aspect of the ivc, common iliac and external iliac veins, common femoral veins and multiple collateral vessels in the abdominal wall.While in the hospital, wound care was done for ulcerations of the right great toe, right lateral malleolus, right heel, left heel and left foot.Approximately one month later, the patient had decreased appetite, nausea, fluid retention and abdominal pain.Ct scan showed a new proximal left femur fracture, ivc filter with occlusion of the ivc with extensive collaterals, gallstones (pre-existing), enlargement of the left adrenal gland (pre-existing) and hiatal hernia.Surgical fixation of the fracture was not indicated.The abdominal pain was related to lovenox injections.Imaging revealed acute dvt of the left common femoral vein.Ct images depict a cordis device in the ivc.Approximately eight years and ten months after implant, the patient was receiving skilled nursing care for ongoing chronic leg wounds related to paraplegia and immobility.Twelve years and eleven months after implant, ongoing anticoagulation regimen changes were noted.At that time, it was noted that the patient had a recent fall from his wheelchair, fracturing both femurs.The fractures were treated conservatively secondary to non-weight bearing status.An episode of bleeding gastric polyps was noted, with treatment via blood transfusion.Coumadin regimen was ongoing.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.Stenosis (scarring) of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Permanent ivc filters have been reported to obstruct in up to 20% of patients.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Varicose veins, while not specifically detailed in the ifu are a known potential event associated to occlusion of the ivc filer, which is a known potential adverse event.With the occlusion of the ivc, the body naturally seeks alternative pathways to achieve return of venous blood to the heart, thus begins the formation of varicose veins in the abdomen.Pain 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.
|
| |
|
Event Description
|
|
As reported by 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, a computed tomography (ct) scan of the patient¿s abdomen showing blocking of his inferior vena cava.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, pain and suffering, and other damages.According to the medical records the patient was admitted to the hospital after an accident involving a farm tractor.The patient sustained a spinal vertebral fracture (fx) resulting in paraplegia with bowel and bladder dysfunction, in addition to multiple displaced left and right rib fractures.While in the hospital the patient experienced a hemothorax, paroxysmal supraventricular tachycardia, deep vein thrombosis(dvt) and bilateral pulmonary embolism (pe).The patient also developed vancomycin-resistant enterococci (vre) and methicillin-resistant staphylococcus aureus (mrsa).Prior to the filter implant, three days after admission, a ct of the abdomen noted an abnormal appearance of to the para-aortic abdominal soft tissues, presumably hemorrhage associated with vertebral fracture.An abnormal lobulated mass involving the left adrenal gland, sludge was noted in the gallbladder and there was diffuse fatty infiltration of the liver.Approximately nineteen days prior to the index procedure the patient had a noted history of dyslipidemia and gastroesophageal reflux disease (gerd).Thoracolumbar spine injury with a need for surgical spinal stabilization.Injuries also included tension pneumothorax.Non-sustained ventricular tachycardia was also noted upon hospitalization.Approximately twenty-one days after admission an ivc filter was implanted for bilateral pe, the need for surgery and discontinuation of heparin therapy.Three days prior, a computed tomography (ct) scan noted bilateral, pulmonary emboli (pe), right greater than left.The largest embolus extended from the right upper lobe pulmonary arterial system down into the right lower lobe system and was almost occlusive within the right lower lobe.Bilateral lower lobe atelectasis.An ultrasound also noted a right peroneal deep vein thrombosis (dvt).The filter was placed via an existing peripherally inserted central catheter (picc) line access site in the left arm.The filter was deployed below the level of the renal veins.A new 6 french dual lumen was cut to the appropriate length and placed over the guidewire and secured in place.Four days later the patient underwent a spinal fusion of t10-l4 and t12-l1 laminectomy.The hospital course was complicated by a left hemothorax and pneumonia.The patient was eventually discharged to a rehabilitation facility approximately one-month post admission.Seven months after the index procedure lumbar spine imaging shows posterior rod fixation of the patient¿s thoracolumbar spine.Seven months and three weeks after the index procedure the patient experienced increasing edema of the left leg, secondary to tractor accident and paraplegia.The patient had skilled nursing care for ongoing chronic leg wounds approximately eight years and ten years after the accident approximately ten months after the index procedure, doppler ultrasound imaging of the lower extremities showed extensive bilateral lower extremity deep vein thrombosis (dvt).Bilateral leg swelling was confirmed to be ivc filter obstructions.Lovenox was started and then the patient was transitioned to coumadin therapy.At that time the patient was on a stable oral anticoagulation regimen, with mild chronic leg swelling noted. the results of abdominal and pelvic computed tomography (ct) scans done approximately one year after the index procedure indicate that the patient experienced chronic thrombosis, scarring of proximal (to the filter) inferior vena cava (ivc) and chronic bilateral iliac thrombosis.The ivc above the filter was widely patent.There were also multiple abdominal varicose veins.The next month the patient was seen in the coumadin clinic office for follow up of dvt and coumadin therapy. approximately four years and eleven months post implant, a ct scan of the thoracic spine was performed due to noise on movement status post-surgery.Results of the scan noted postsurgical changes with fracture of the right paravertebral rod just above the level of the l2 pedicle screw, suspected loosening of the left t11 and t12 pedicle screws, degenerative changes, hiatal hernia, fatty liver (pre-existing), cholelithiasis (pre-existing).Approximately seven years and seven months post implant the patient was seen in the emergency room (er) for back pain radiating to the abdomen.A ct scan of the abdomen was performed and noted a moderate sized hilar hernia.The inferior vena cava (ivc) inferior to the filter was threadlike and appeared to be occluded, there are multiple venous collaterals involving the anterior abdominal wall.The patient was diagnosed with a stable hernia and discharged to home.Approximately eight years post implant the patient was admitted to the er with abdominal pain and fever, a urinary tract infection (uti) was diagnosed.A ct scan of the abdomen was performed for diagnostic purposes and showed chronic arthritis bilateral hips, unchanged and a mass like configuration of the left adrenal gland (pre-existing).The remainder of the ct scan was within normal limits.The ivc filter was in place.From the level of the inferior margin of the ivc filter there was an extremely tiny sized chronically occluded inferior aspect of the ivc, common iliac and external iliac veins, common femoral veins and multiple collateral vessels in the abdominal wall.While in the hospital the patient was seen by a wound care nurse for ulcerations of the right great toe, right lateral malleolus, right heel, left heel and left foot.Approximately one month later the patient presented for evaluation of decreased appetite, nausea, fluid retention and abdominal pain.Ct scan of the abdomen noted a new proximal left femur fracture, surgery not indicated, ivc filter with occlusion of the ivc with extensive collaterals, gallstones (pre-existing), enlargement of the left adrenal gland (pre-existing) and hiatal hernia.Abdominal pain was determined to be from lovenox injections.Venous duplex ultrasound revealed acute dvt of the left common femoral vein.Subsequently, the patient was discharged with home health.Ct images were provided, the images depict a device that was similar in shape to a cordis device, no further information can be gleaned from the images.Approximately eight years and ten years after the accident the patient still had skilled nursing care for ongoing chronic leg wounds.Twelve years and eleven months after the index procedure the patient was seen in a coumadin clinic office for follow up of dvt and coumadin therapy.It was noted at that time that the patient had a recent fall from his wheelchair, fracturing both femurs.The fractures were treated conservatively secondary to non-weight bearing status.An episode of bleeding gastric polyps was noted, with treatment via blood transfusion.Coumadin regimen ongoing.
|
| |
|
Manufacturer Narrative
|
|
After further review of additional information received, the following sections have been updated accordingly: b4, g3, g6, h1, h2 and h6.As reported, the patient had placement of a trapease inferior vena cava (ivc) filter.The filter malfunctioned and caused injury including ivc occlusion.Per the medical records, the indication was trauma from a farm tractor accident, resulting in spinal vertebral fractures (fx), paraplegia with bowel and bladder dysfunction, in addition to multiple displaced left and right rib fractures.While in the hospital the patient experienced hemothorax, paroxysmal supraventricular tachycardia, non-sustained ventricular tachycardia, deep vein thrombosis (dvt) and bilateral pulmonary embolism (pe).Medical history at this time includes gerd and dyslipidemia.The patient also developed drug resistant infections of vre and mrsa.Prior to the filter implant, a ct noted an abdominal hemorrhage associated with vertebral fracture.Also noted were a left adrenal gland lobulated mass involving the left adrenal gland, gallbladder sludge and diffuse fatty infiltration of the liver.Approximately twenty-one days after admission, an ultrasound also noted a right peroneal deep vein thrombosis (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.Four days later the patient underwent a spinal fusion of t10-l4 and t12-l1 laminectomy.The patient was eventually discharged to a rehabilitation facility approximately one-month post admission.Seven months after implant, imaging shows posterior rod fixation of the thoracolumbar spine.Three weeks after this imaging, the patient had increasing edema of the left leg.Approximately ten months after implant, imaging showed extensive bilateral lower dvt, with ivc filter obstruction and mild chronic leg swelling.Anticoagulation regimen was initiated and adjusted.Approximately one year after implant, ct imaging showed chronic thrombosis of and scarring of the ivc proximal to the filter, along with chronic bilateral iliac thrombosis.The ivc above the filter was widely patent.There were also multiple abdominal varicose veins.Ongoing medication regimen adjustments were noted.Approximately four years and eleven months post implant, a ct scan noted postsurgical changes with fracture of the right paravertebral rod just above the level of the l2 pedicle screw, suspected loosening of the left t11 and t12 pedicle screws, degenerative changes, hiatal hernia, fatty liver (pre-existing), cholelithiasis (pre-existing).Approximately seven years and seven months post implant, the patient had back pain radiating to the abdomen.A ct scan showed a moderate sized hilar hernia.The ivc inferior to the filter was threadlike and appeared to be occluded, with multiple venous collaterals involving the anterior abdominal wall.Approximately eight years post implant, the patient had abdominal pain and fever, and was diagnosed with a urinary tract infection (uti).A ct scan showed chronic arthritis bilateral hips, unchanged and a mass like configuration of the left adrenal gland (pre-existing).The ivc filter was in place.From the level of the inferior margin of the ivc filter there was an extremely tiny sized chronically occluded inferior aspect of the ivc, common iliac and external iliac veins, common femoral veins and multiple collateral vessels in the abdominal wall.While in the hospital, wound care was done for ulcerations of the right great toe, right lateral malleolus, right heel, left heel and left foot.Approximately one month later, the patient had decreased appetite, nausea, fluid retention and abdominal pain.Ct scan showed a new proximal left femur fracture, ivc filter with occlusion of the ivc with extensive collaterals, gallstones (pre-existing), enlargement of the left adrenal gland (pre-existing) and hiatal hernia.Surgical fixation of the fracture was not indicated.The abdominal pain was related to lovenox injections.Imaging revealed acute dvt of the left common femoral vein.Ct images depict a cordis device in the ivc.Approximately eight years and ten months after implant, the patient was receiving skilled nursing care for ongoing chronic leg wounds related to paraplegia and immobility.Twelve years and eleven months after implant, ongoing anticoagulation regimen changes were noted.At that time, it was noted that the patient had a recent fall from his wheelchair, fracturing both femurs.The fractures were treated conservatively secondary to non-weight bearing status.An episode of bleeding gastric polyps was noted, with treatment via blood transfusion.Coumadin regimen was ongoing.Additional information received indicated approximately eight years and one month post implant the patient presented with a left hip fracture.Surgical repair was not performed as the patient was not experiencing pain and it appeared to be healing.The patient was found to have an acute left lower extremity deep vein thrombosis (dvt).He was kept on heparin.The hip fracture was monitored over several months.Due to moderate swelling of the affected leg, surgery was requested by the patient and a left hip intramedullary nailing was performed three months later.Two months after that, the patient was seen in the office for a pre-existing heal wound that had re-opened.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.Stenosis (scarring) of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Permanent ivc filters have been reported to obstruct in up to 20% of patients.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Varicose veins, while not specifically detailed in the ifu are a known potential event associated to occlusion of the ivc filer, which is a known potential adverse event.With the occlusion of the ivc, the body naturally seeks alternative pathways to achieve return of venous blood to the heart, thus begins the formation of varicose veins in the abdomen.Pain 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.
|
| |
|
Event Description
|
|
Approximately eight years and one month after the index procedure the patient presented with a left hip fracture.Surgical repair was not performed as the patient was not experiencing pain and it appeared to be healing.The patient was found to have an acute left lower extremity deep vein thrombosis (dvt).He was kept on heparin.The hip fracture was monitored over several months.Due to moderate swelling of the affected leg, surgery was requested by the patient and a left hip intramedullary nailing was performed three months later.Two months after that, the patient was seen in the office for a pre-existing heal wound that had re-opened.
|
| |
|
Manufacturer Narrative
|
|
Additional information is pending and will be submitted within 30 days of receipt.
|
| |
|
Search Alerts/Recalls
|
|
|
