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| Catalog Number 466F220A |
| Device Problems
Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026); Migration (4003)
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| Patient Problems
Pulmonary Embolism (1498); Myocardial Infarction (1969); Occlusion (1984); Perforation (2001); Thrombosis (2100); Thrombus (2101); Perforation of Vessels (2135)
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| Event Date 01/01/2017 |
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Event Type
Injury
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Manufacturer Narrative
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It was reported that a patient underwent placement of a optease 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, deep vein thrombosis (dvt), pulmonary embolism (pe), post-thrombotic syndrome, swelling and pain.The information indicated that as a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment and as a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffered, and other damages.The is currently no additional information available.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 optease 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 that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Recurring deep vein thrombosis 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 be confirmed, nor is it possible to establish a relationship between the reported events and the device.Post-thrombotic syndrome (pts) is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis (blood clot) in the leg.Pts symptoms include chronic leg pain, swelling, redness, and ulcers (sores).As the patient¿s medical history has not been provided, it is not possible to determine a relationship between the events and the device.Swelling, pain and post-thrombotic syndrome do not represent a device malfunction and may be related to underlying patient specific issues and/or pre-existing patient conditions.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.Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available.If obtained, a follow up report will be submitted within 30 days upon receipt.
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Event Description
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As reported by the legal brief, the patient underwent placement of optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, deep vein thrombosis (dvt), pulmonary embolism (pe), post-thrombotic syndrome, swelling and pain.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.
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Manufacturer Narrative
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After further review of additional information received the following sections have been updated accordingly.As reported, the patient underwent placement of optease inferior vena cava (ivc) filter.Per the medical records, the patient underwent placement of the inferior vena cava (ivc) due to their history of deep vein thrombosis (dvt) and pulmonary embolism (pe) while on anticoagulation.During placement of the filter via the right femoral vein, an optease catheter was inserted just below the level of the lower line right renal vein and it was deployed without complications.A completion venogram was performed which demonstrated good location of the filter and patency of the renal veins.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, deep vein thrombosis (dvt), pulmonary embolism (pe), post-thrombotic syndrome, swelling and pain.Approximately nine months and a year post filter implant, the patient presented with leg swelling and in both admissions an ultrasound venous doppler was performed and revealed persistent changes of occlusive thrombus in the common femoral level and throughout the femoral vein of the thigh.Although a computerized tomography (ct) of the chest was performed because of the patient complaining of chest pain and shortness of breath which showed no gross sign of pe.Approximately eight months later, the patient presented with chest pain however ct scan of the chest was negative for pe and a chest x-ray was showed a cardiac assist device has been inserted with its lead overlying the right ventricle.An ultrasound venous doppler presented with similar results to previous studies.Almost a year later, the patient presented with shortness of and hemoptysis.Ct of the chest showed no evidence of pe but noted a left adrenal adenoma and cardiomegaly.The patient also had a chest x-ray for congestion which revealed no acute cardiopulmonary process.According to the information received in the patient profile form, the patient reported heart attack, blood clots, clotting, and/or occlusion of the ivc.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 optease 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, pulmonary embolism, post thrombotic syndrome and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Chest pain, heart attack, shortness of breath, swelling and pain do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
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Manufacturer Narrative
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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, the patient underwent placement of optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, deep vein thrombosis (dvt), pulmonary embolism (pe), post-thrombotic syndrome, swelling and pain.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) due to their history of deep vein thrombosis (dvt) and pulmonary embolism (pe) while on anticoagulation.During placement of the filter via the right femoral vein, an optease catheter was inserted just below the level of the lower line right renal vein and it was deployed without complications.A completion venogram was performed which demonstrated good location of the filter and patency of the renal veins.The patient tolerated the procedure well.Two days post implant, a chest x-ray was performed on the patient because of a fever.The exam revealed minimal atelectasis in the medial left lower lobe otherwise the lungs were clear.The same day, a bilateral upper extremity venous doppler was performed because of pain, swelling, and infection at the intravenous (iv) site on the right arm.The ultrasound revealed a right cephalic vein thrombosis.Blood cultures taken of the wound site were positive for mssa bacteremia.The patient continued to be treated with iv antibiotics for the rest of the hospital stay.A picc line was in order for the patient to receive home iv antibiotic therapy for two more weeks.Three days later, a transvaginal ultrasound revealed a fibroid uterus.During this hospital stay the patient was also seen my hematology and it was discovered that the patient had a positive lupus anticoagulant and was to remain fully anticoagulated.At an unspecified time during this hospital admission, the patient also had some breakthrough seizures.Neurology recommended the continuation on keppra administration for the patient.Approximately nine months and a year post filter implant, the patient presented with leg swelling and in both admissions an ultrasound venous doppler was performed and revealed persistent changes of occlusive thrombus in the common femoral level and throughout the femoral vein of the thigh.Although a computerized tomography (ct) of the chest was performed because of the patient complaining of chest pain and shortness of breath which showed no gross sign of pe.Approximately eight months later, the patient presented with chest pain however ct scan of the chest was negative for pe and a chest x-ray was showed a cardiac assist device has been inserted with its lead overlying the right ventricle.An ultrasound venous doppler presented with similar results to previous studies.Almost a year later, the patient presented with shortness of and hemoptysis.Ct of the chest showed no evidence of pe but noted a left adrenal adenoma and cardiomegaly.The patient also had a chest xray for congestion which revealed no acute cardiopulmonary process.
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Manufacturer Narrative
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After further review of additional information received the following sections have been updated accordingly.A review of the manufacturing documentation associated with this lot 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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Manufacturer Narrative
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As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of hypertension, seizures, hypokalemia, heavy menstrual periods, smoking and polysubstance abuse.Diagnostic testing at the time of admission revealed toxicology results that were positive for cannabinoids, cocaine and opiates.The indication for the filter placement was reported to be a left lower extremity deep vein thrombosis (dvt) and pulmonary embolism (pe) while on anticoagulation.The filter was implanted via the right femoral vein and placed just below the level of the lower line of the right renal vein.The patient is reported to have tolerated the procedure well and without complications.Approximately nine months after the filter implantation, the patient presented with leg swelling.Diagnostic testing revealed persistent changes of occlusion thrombus in the femoral vein at the level of the common femoral.Approximately one year after the filter implantation, the patient again presented with leg swelling with similar persistent changes of occlusion thrombus in the femoral vein at the level of the common femoral.The patient reported having experienced chest pain and shortness of breath (sob), but diagnostic testing ruled out evidence of a pe.Eight months later, the patient developed chest pain.Diagnostic testing was again negative for pe but revealed evidence of a cardiac assist device with its¿ lead overlying the right ventricle.Approximately one year later, the patient again presented with sob, hemoptysis and congestion.Diagnostic testing revealed no evidence of pe or acute cardiopulmonary process but noted a left adrenal adenoma and cardiomegaly.Approximately four years and ten months after the filter implantation, the patient became aware that the filter had tilted, fractured and migrated.The filter was also reported to have been associated with perforation of the inferior vena cava (ivc) abutting an organ.The patient also reported having developed post-thrombotic syndrome, recurrent dvt and pe.The patient further reported having experienced leg swelling, pain, a heart attack, mental anguish, worry and anxiety associated with the filter.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 optease retrievable 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 images or procedural films for review, the reported filter tilt, migration, fracture and perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.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 ivc 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 timing and mechanism of the fracture has not been reported at this time.The ifu states that 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.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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.Stenosis, blood clots, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Recurrent pe is a known potential complication of filter implantation and is listed in the ifu as such.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Post-thrombotic syndrome is a problem that can develop in nearly half of all patients who experience a dvt.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Due to the nature of the complaint, the reported pain, swelling, heart attack and sob 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.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
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Event Description
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As reported by the legal brief, the patient underwent placement of optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, deep vein thrombosis (dvt), pulmonary embolism (pe), post-thrombotic syndrome, swelling and pain.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) due to their history of deep vein thrombosis (dvt) and pulmonary embolism (pe) while on anticoagulation.During placement of the filter via the right femoral vein, an optease catheter was inserted just below the level of the lower line right renal vein and it was deployed without complications.A completion venogram was performed which demonstrated good location of the filter and patency of the renal veins.The patient tolerated the procedure well.Two days post implant, a chest x-ray was performed on the patient because of a fever.The exam revealed minimal atelectasis in the medial left lower lobe otherwise the lungs were clear.The same day, a bilateral upper extremity venous doppler was performed because of pain, swelling, and infection at the intravenous (iv) site on the right arm.The ultrasound revealed a right cephalic vein thrombosis.Blood cultures taken of the wound site were positive for mssa bacteremia.The patient continued to be treated with iv antibiotics for the rest of the hospital stay.A peripherally inserted central catheter (picc) line was in order for the patient to receive home iv antibiotic therapy for two more weeks.Three days later, a transvaginal ultrasound revealed a fibroid uterus.During this hospital stay the patient was also seen my hematology and it was discovered that the patient had a positive lupus anticoagulant and was to remain fully anticoagulated.At an unspecified time during this hospital admission, the patient also had some breakthrough seizures.Neurology recommended the continuation on keppra administration for the patient.Approximately nine months and a year post filter implant, the patient presented with leg swelling and in both admissions an ultrasound venous doppler was performed and revealed persistent changes of occlusive thrombus in the common femoral level and throughout the femoral vein of the thigh.Although a computerized tomography (ct) of the chest was performed because of the patient complaining of chest pain and shortness of breath which showed no gross sign of pe.Approximately eight months later, the patient presented with chest pain however ct scan of the chest was negative for pe and a chest x-ray was showed a cardiac assist device has been inserted with its lead overlying the right ventricle.An ultrasound venous doppler presented with similar results to previous studies.Almost a year later, the patient presented with shortness of and hemoptysis.Ct of the chest showed no evidence of pe but noted a left adrenal adenoma and cardiomegaly.The patient also had a chest xray for congestion which revealed no acute cardiopulmonary process.According to the updated legal brief provided, the filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, fracture, migration, perforation, tilting and perforation abutting an adjacent organ.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately four years and ten months after the filter implantation.The patient reports ivc perforation, migration, perforation abutting an organ, tilting and fracture of the filter with fractured filter struts retained within the ivc.The patient further experienced anxiety related to the filter.
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Manufacturer Narrative
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As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of hypertension, seizures, hypokalemia, heavy menstrual periods, smoking and polysubstance abuse.Diagnostic testing at the time of admission revealed toxicology results that were positive for cannabinoids, cocaine and opiates.The indication for the filter placement was reported to be a left lower extremity deep vein thrombosis (dvt) and pulmonary embolism (pe) while on anticoagulation.The filter was implanted via the right femoral vein and placed just below the level of the lower line of the right renal vein.The patient is reported to have tolerated the procedure well and without complications.Approximately nine months after the filter implantation, the patient presented with leg swelling.Diagnostic testing revealed persistent changes of occlusion thrombus in the femoral vein at the level of the common femoral.Approximately one year after the filter implantation, the patient again presented with leg swelling with similar persistent changes of occlusion thrombus in the femoral vein at the level of the common femoral.The patient reported having experienced chest pain and shortness of breath (sob), but diagnostic testing ruled out evidence of a pe.Eight months later, the patient developed chest pain.Diagnostic testing was again negative for pe but revealed evidence of a cardiac assist device with its¿ lead overlying the right ventricle.Approximately one year later, the patient again presented with sob, hemoptysis and congestion.Diagnostic testing revealed no evidence of pe or acute cardiopulmonary process but noted a left adrenal adenoma and cardiomegaly.Approximately four years and ten months after the filter implantation, the patient became aware that the filter had tilted, fractured and migrated.The filter was also reported to have been associated with perforation of the inferior vena cava (ivc) abutting an organ.The patient also reported having developed post-thrombotic syndrome, recurrent dvt and pe.The patient further reported having experienced leg swelling, pain, a heart attack, mental anguish, worry and anxiety associated with the filter.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 optease retrievable 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 images or procedural films for review, the reported filter tilt, migration, fracture and perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.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 ivc 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 timing and mechanism of the fracture has not been reported at this time.The ifu states that 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.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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.Stenosis, blood clots, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Recurrent pe is a known potential complication of filter implantation and is listed in the ifu as such.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Post-thrombotic syndrome is a problem that can develop in nearly half of all patients who experience a dvt.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Due to the nature of the complaint, the reported pain, swelling, heart attack and sob 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.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
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Event Description
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As reported by the legal brief, the patient underwent placement of optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, deep vein thrombosis (dvt), pulmonary embolism (pe), post-thrombotic syndrome, swelling and pain.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 information received in the patient profile form (ppf), the patient reported blood clots, clotting, and/or occlusion of the inferior vena cava (ivc).Per the medical records, the patient underwent placement of the inferior vena cava (ivc) due to a history of deep vein thrombosis (dvt) and pulmonary embolism (pe) while on anticoagulation.During placement of the filter via the right femoral vein, an optease catheter was inserted just below the level of the lower right renal vein and it was deployed without complications.A completion venogram was performed which demonstrated good location of the filter and patency of the renal veins.The patient tolerated the procedure well.Two days post implant, a chest x-ray was performed on the patient because of a fever.The exam revealed minimal atelectasis in the medial left lower lobe; otherwise the lungs were clear.The same day, a bilateral upper extremity venous doppler was performed because of pain, swelling, and infection at the intravenous (iv) site on the right arm.The ultrasound revealed a right cephalic vein thrombosis.Blood cultures taken of the wound site were positive for methicillin-susceptible staphylococcus aureus (mssa) bacteremia.The patient continued to be treated with iv antibiotics for the rest of the hospital stay.A peripherally inserted central catheter (picc) line was in order for the patient to receive home iv antibiotic therapy for two more weeks.Three days later, a transvaginal ultrasound revealed a fibroid uterus.During this hospital stay the patient was also seen by hematology and it was discovered that the patient had a positive lupus anticoagulant and was to remain fully anticoagulated.At an unspecified time during this hospital admission, the patient also had some breakthrough seizures.Neurology recommended the continuation on keppra administration for the patient.Approximately nine months and a year post filter implant, the patient presented with leg swelling and in both admissions an ultrasound venous doppler was performed revealing persistent changes of occlusive thrombus in the common femoral level and throughout the femoral vein of the thigh.A computerized tomography (ct) of the chest was performed because of the patient complaining of chest pain and shortness of breath which showed no gross sign of pe.Approximately eight months later, the patient presented with chest pain; however, a ct scan of the chest was negative for pe and a chest x-ray showed that a cardiac assist device had been inserted with its lead overlying the right ventricle.An ultrasound venous doppler presented with similar results to previous studies.Almost a year later, the patient presented with shortness of breath and hemoptysis.A ct of the chest showed no evidence of pe but noted a left adrenal adenoma and cardiomegaly.The patient also had a chest x-ray for congestion which revealed no acute cardiopulmonary process.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc, blood clots, clotting, occlusion of the ivc and fractured filter struts retained in the inferior vena, becoming aware of these events about two years and two months after the filter implantation.The patient further experienced a heart attack, recurrent dvt, swelling of the legs and anxiety related to the filter.According to the updated legal brief provided, the filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to migration, perforation, tilting and perforation abutting an adjacent organ becoming aware of the reported events approximately four years and ten months after the filter implantation.The patient additionally reports perforation of filter struts outside the ivc, perforation abutting an organ, filter tilting and migration.
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Search Alerts/Recalls
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