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| Catalog Number 466F220A |
| Device Problems
Fracture (1260); Unintended Movement (3026)
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| Patient Problems
Syncope (1610); Perforation (2001); Tachycardia (2095); Thrombosis (2100); No Code Available (3191)
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| Event Date 11/29/2016 |
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Event Type
Injury
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Manufacturer Narrative
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Please note that the exact event date is unknown and that the event date is the complaint awareness date.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, reoccurring events of the ivc filter perforating her inferior vena cava wall, the filter fracturing, a fragment of her ivc filter migrated to her right atrium causing severe tachycardia, and syncope.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment, including open heart surgery.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.No additional information is available.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The optease filter is indicated for use in the prevention of recurrent pulmonary embolism.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 filter fracture/separated and migration could not be confirmed and the exact cause could not be determined.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 and migration of fractured struts could not be confirmed and the exact cause could not be determined.A clinical factor contributing to the migration could not be determined.The brief also reported perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.Without procedural films for review, the reported ivc perforation could not be confirmed and the exact cause could not be determined.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.However, 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.Please note that this is the initial/final report for this product.
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Event Description
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As reported through the legal department via a legal brief, the patient underwent placement of an optease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, several tines of the ivc filter perforating her inferior vena cava wall, the filter fracturing, a fragment of her ivc filter migrated to her right atrium causing severe tachycardia, and syncope.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment, including open heart surgery.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.No additional information is available.
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Manufacturer Narrative
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As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of thrombus within the abdominal vessels, abnormality of the ivc, a total abdominal hysterectomy (tah), chronic renal disease (crd) with menopausal symptoms successfully treated with effexor, motor vehicle accident, chest pain, shortness of breath, fracture of the right wrist with altered consciousness secondary to trauma, cervical spine degenerative changes, remote history of breast mass excision, recurrent paroxysmal atrial fibrillation (afib), diabetes, gerd, essential hypertension (htn), thyroid nodules, and abnormal pap smear.The filter was placed in an l1-l3 position within the ivc without any reported complications.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the ivc filter perforating the inferior vena cava wall several times, the filter fracturing, a fragment of the ivc filter migrating to the right atrium and perforating the right atrium causing severe tachycardia, and syncope.In 2010 the patient experienced back pain, dizziness, gait disorder and a mass plug of thrombosis was discovered in the ivc filer and there was a liver cyst.In 2015, the patient had an mrv of the pelvis that revealed thrombosis in the ivc and that the filter had migrated into the intra-hepatic vena cava.It was also noted, that several filter tines were seen extending beyond the wall of the ivc, however no hemorrhage was noted.Also, at this time, the patient was having recurrent cardiac arrhythmias.Imaging in 2016 revealed a filter strut within the right ventricular chamber, trapped between the myocardium and the trabeculae.The patient was considered high risk for removal surgery, so it was decided to observe and treat conservatively.Late in 2016, the patient went to an interventional radiology (ir) specialist for consult on percutaneous filter removal.A computerized tomography (ct) angio of the thoracic aorta with ecg showed the fractured ivc filter had migrated and now lies in the inferior vena cava at its course through the liver, above the drainage of the right and left renal veins.Atria was dilated without filling defects.Linear metallic density is noted along the posterior wall of the right ventricle, with one end abutting the myocardium and the other end tangled within the chamber trabeculae.Neither and pointed towards the right ventricle (rv) cavity.Struts measured approximately 1cm in length.A percutaneous removal of the ivc filter using laser excimer assist was successfully done.However, two small fragments remained, probably embedded in the vena cava wall or potentially extra caval.They were unable to retrieve a fragment from the pulmonary artery; however, during the attempt to retrieve this, the strut migrated to the abdominal aorta through an open atrial-septal defect, where it was successfully retrieved.There was no vena caval thrombosis noted.Ct imaging after removal identified the strut still in position in the right ventricle.The patient recovered and was discharged home with the plan to do open heart removal of the remaining strut as well as treatment for atrial fibrillation.The patient returned to the hospital and underwent an open ventriculotomy with removal of filter strut, repair of rv and closure of atrial septal defect, pulmonary vein isolation and ligation of the left atrial appendage (to treat the afib).The patient was started back on anticoagulation therapy after the post-operative course.Since restarting on anti-coagulants, the patient has experienced gastric bleeding.The patient has also had keloid scarring develop on the thoracic incision done for strut removal.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment, including open heart surgery.The filter is unavailable for analysis.The product was not returned for analysis.A review of the device history record (dhr) associated with lot 15029735 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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.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.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots and thrombosis within the filter do not represent a device malfunction.Back pain, tachycardia, and syncope maybe related to the portion of the device that migrated to the heart structures.Gait disorder 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.
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Manufacturer Narrative
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The patient has a history of thrombus within the abdominal vessels, abnormality of the ivc, a total abdominal hysterectomy (tah), chronic renal disease (crd) with menopausal symptoms successfully treated with effexor, motor vehicle accident, chest pain, shortness of breath, fracture of the right wrist with altered consciousness secondary to trauma, cervical spine degenerative changes, remote history of breast mass excision, recurrent paroxysmal atrial fibrillation (afib), diabetes, gerd, essential hypertension (htn), thyroid nodules, and abnormal pap smear.In 2010 the patient experienced back pain, dizziness, gait disorder and a mass plug of thrombosis was discovered in the ivc filer and there was a liver cyst.The filter was placed in an l1-l3 position within the ivc without any reported complications.In 2015, the patient had an mrv of the pelvis that revealed thrombosis in the ivc and that the filter had migrated into the intra-hepatic vena cava.It was also noted, that several filter tines were seen extending beyond the wall of the ivc, however no hemorrhage was noted.Also, at this time, the patient was having recurrent cardiac arrhythmias.Imaging in 2016 revealed a filter strut within the right ventricular chamber, trapped between the myocardium and the trabeculae.The patient was considered high risk for removal surgery, so it was decided to observe and treat conservatively.Late in 2016, the patient went to an interventional radiology (ir) specialist for consult on percutaneous filter removal.A computerized tomography (ct) angio of the thoracic aorta with ecg showed the fractured ivc filter had migrated and now lies in the inferior vena cava at its course through the liver, above the drainage of the right and left renal veins.Atria was dilated without filling defects.Linear metallic density is noted along the posterior wall of the right ventricle, with one end abutting the myocardium and the other end tangled within the chamber trabeculae.Neither and pointed towards the right ventricle (rv) cavity.Struts measured approximately 1cm in length.A percutaneous removal of the ivc filter using laser excimer assist was successfully done.However, two small fragments remained, probably embedded in the vena cava wall or potentially extra caval.They were unable to retrieve a fragment from the pulmonary artery; however, during the attempt to retrieve this, the strut migrated to the abdominal aorta through an open atrial-septal defect, where it was successfully retrieved.There was no vena caval thrombosis noted.Ct imaging after removal identified the strut still in position in the right ventricle.The patient recovered and was discharged home with the plan to do open heart removal of the remaining strut as well as treatment for atrial fibrillation.The patient returned to the hospital, and underwent an open ventriculotomy with removal of filter strut, repair of rv and closure of atrial septal defect, pulmonary vein isolation and ligation of the left atrial appendage (to treat the afib).The patient was started back on anticoagulation therapy after the post-operative course.Since restarting on anti-coagulants, the patient has experienced gastric bleeding.The patient has also had keloid scarring develop on the thoracic incision done for strut removal.A review of the manufacturing documentation associated with lot 15029735 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
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Manufacturer Narrative
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Initial reporter occupation: other, paralegal.Patient code '3191' was used as there are no codes available for 'wenkenback'.The patient has also had keloid scarring develop on the thoracic incision done for strut removal.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment, including open heart surgery.Additional information received per the medical records indicate that the patient has a history of arthritis, extended abdominoplasty surgery, migraines, angioedema and supraventricular tachycardia (hcc).The medical records state that the patient was implanted with the inferior vena cava filter urgently due to an inferior vena cava clot.The medical records state that after implantation of the device, the patient has experienced periods of wenkenback (possibly related to the embolized struts in the right venticleb).After the device was explanted, the patient experienced anxiety, shortness of breath (lungs were clear with no wheezing, symptom resolved) and after re-starting anticoagulation therapy the patient experienced gastrointestinal bleeding from diverticulitis (without a specific bleeding site).The patient is currently taking part in a black cohosh trial for hot flashes due to surgical menopause.Additional information is pending and will be submitted within 30 days of receipt.
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Manufacturer Narrative
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Section b5: information received per additional medical records state that the patient had a history of coronary artery disease and a history of long-term anticoagulation therapy.Post implantation, the patient experienced episodes of gastrointestinal bleeding that were related to anticoagulation treatment.As such, the patient¿s anticoagulation therapy dosage was adjusted.Two years after the device was explanted, the patient fell and experienced shoulder and knee pain that were treated with steroid injections.Two years after the device was explanted the patient also experienced carpal tunnel syndrome in her left wrist.As reported, the patient had placement of an optease inferior vena cava (ivc) filter.The patient has a history of thrombus within the abdominal vessels, abnormality of the ivc, a total abdominal hysterectomy (tah), chronic renal disease (crd) with menopausal symptoms successfully treated with effexor, motor vehicle accident, chest pain with coronary artery disease, shortness of breath, fracture of the right wrist with altered consciousness secondary to trauma, cervical spine degenerative changes, remote history of breast mass excision, recurrent paroxysmal atrial fibrillation (afib), diabetes, gerd, essential hypertension (htn), thyroid nodules, and abnormal pap smear.In 2010 the patient experienced back pain, dizziness, gait disorder and imaging found a liver cyst and a mass plug of thrombosis was discovered in the ivc.The filter was placed in an l1-l3 position within the ivc without any reported complications.The filter subsequently malfunctioned and caused injury and damages to the patient, including the ivc filter perforating the inferior vena cava wall, the filter fracturing, a fragment of the ivc filter migrating and perforating the right atrium.In 2015, the patient had imaging revealed thrombosis in the ivc and that the filter had migrated into the intra-hepatic vena cava.It was also noted, that several filter tines were seen extending beyond the wall of the ivc, however no hemorrhage was noted.Also, at this time, the patient was having recurrent cardiac arrhythmias.Imaging in 2016 revealed a filter strut within the right ventricular chamber, trapped between the myocardium and the trabeculae.The patient was considered high risk for removal surgery, so it was decided to observe and treat conservatively.Late in 2016, the patient went to an interventional radiology (ir) specialist for consult on percutaneous filter removal.A computerized tomography (ct) angio of the thoracic aorta with ecg showed the fractured ivc filter had migrated and now lies in the inferior vena cava at its course through the liver, above the drainage of the right and left renal veins.Atria was dilated without filling defects.Linear metallic density is noted along the posterior wall of the right ventricle, with one end abutting the myocardium and the other end tangled within the chamber trabeculae.Neither and pointed towards the right ventricle (rv) cavity.Struts measured approximately 1cm in length.A percutaneous removal of the ivc filter using laser excimer assist was successfully done.However, two small fragments remained, probably embedded in the vena cava wall or potentially extra caval.They were unable to retrieve a fragment from the pulmonary artery; however, during the attempt to retrieve this, the strut migrated to the abdominal aorta through an open atrial-septal defect, where it was successfully retrieved.There was no vena caval thrombosis noted.Ct imaging after removal identified the strut still in position in the right ventricle.The patient recovered and was discharged home with the plan to do open heart removal of the remaining strut as well as treatment for atrial fibrillation.The patient returned to the hospital and underwent an open ventriculotomy with removal of filter strut, repair of rv and closure of atrial septal defect, pulmonary vein isolation and ligation of the left atrial appendage (for the afib).The patient was restarted on anticoagulation therapy.Since restarting on anti-coagulants, the patient has experienced gastric bleeding.Post implantation, the patient experienced episodes of gastrointestinal bleeding that were related to anticoagulation treatment.As such, the patient¿s anticoagulation therapy dosage was adjusted.Two years after the device was explanted, the patient fell and experienced shoulder and knee pain and carpal tunnel syndrome.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.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.The instructions for use (ifu) states filter fracture with perforation 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 was reported that there was perforation of the ivc and other 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Tachycardia and wenckebach, back pain, gait disorder and syncope may be related to the reported device 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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Section b5: as reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The patient has a history of thrombus within the abdominal vessels, abnormality of the ivc, a total abdominal hysterectomy (tah), chronic renal disease (crd) with menopausal symptoms successfully treated with effexor, motor vehicle accident, chest pain, shortness of breath, fracture of the right wrist with altered consciousness secondary to trauma, cervical spine degenerative changes, remote history of breast mass excision, recurrent paroxysmal atrial fibrillation (afib), diabetes, gerd, essential hypertension (htn), thyroid nodules, and abnormal pap smear.Additional information received per the medical records indicate that the patient has a history of arthritis, extended abdominoplasty surgery, migraines, angioedema and supraventricular tachycardia (hcc).The medical records state that the patient was implanted with the intra vena cava filter urgently due to an inferior vena cava clot.The filter was placed in an l1-l3 position within the ivc without any reported complications.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, the ivc filter perforating the inferior vena cava wall several times, filter fracturing, a fragment migrating and perforating the right atrium causing severe tachycardia, and syncope.In 2010 the patient experienced back pain, dizziness, gait disorder and a mass plug of thrombosis was discovered in the ivc filer and there was a liver cyst.In 2015, the patient had an mrv of the pelvis that revealed thrombosis in the ivc and that the filter had migrated into the intra-hepatic vena cava.It was also noted, that several filter tines were seen extending beyond the wall of the ivc, however no hemorrhage was noted.Also, at this time, the patient was having recurrent cardiac arrhythmias.Imaging in 2016 revealed a filter strut within the right ventricular chamber, trapped between the myocardium and the trabeculae.The patient was considered high risk for removal surgery, so it was decided to observe and treat conservatively.Late in 2016, the patient went to an interventional radiology (ir) specialist for consult on percutaneous filter removal.A computerized tomography (ct) angio of the thoracic aorta with ecg showed the fractured ivc filter had migrated and now lies in the inferior vena cava at its course through the liver, above the drainage of the right and left renal veins.Atria was dilated without filling defects.Linear metallic density is noted along the posterior wall of the right ventricle, with one end abutting the myocardium and the other end tangled within the chamber trabeculae.Neither and pointed towards the right ventricle (rv) cavity.Struts measured approximately 1cm in length.A percutaneous removal of the ivc filter using laser excimer assist was successfully done.However, two small fragments remained, probably embedded in the vena cava wall or potentially extra caval.They were unable to retrieve a fragment from the pulmonary artery; however, during the attempt to retrieve this, the strut migrated to the abdominal aorta through an open atrial-septal defect, where it was successfully retrieved.There was no vena caval thrombosis noted.Ct imaging after removal identified the strut still in position in the right ventricle.The patient recovered and was discharged home with the plan to do open heart removal of the remaining strut as well as treatment for atrial fibrillation.The patient returned to the hospital and underwent an open ventriculotomy with removal of filter strut, repair of rv and closure of atrial septal defect, pulmonary vein isolation and ligation of the left atrial appendage (to treat the afib).The patient was started back on anticoagulation therapy after the post-operative course.Since restarting on anti-coagulants, the patient has experienced gastric bleeding.The patient has also had keloid scarring develop on the thoracic incision done for strut removal.The medical records state that after implantation of the device, the patient has experienced periods of wenckebach (possibly related to the embolized struts in the right ventricle).After the device was explanted, the patient experienced anxiety, shortness of breath (lungs were clear with no wheezing, symptom resolved) and after re-starting anticoagulation therapy the patient experienced gastrointestinal bleeding from diverticulitis (without a specific bleeding site).The patient is currently taking part in a black cohosh trial for hot flashes due to surgical menopause.The filter is unavailable for analysis.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.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.The instructions for use (ifu) states filter fracture with perforation 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 was reported that there was perforation of the ivc and other 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Tachycardia and wenckebach, back pain, gait disorder and syncope may be related to the reported device issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
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Event Description
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Six years and five months after the index procedure the patient underwent inferior vena cavography, laser sheath assisted retrieval of inferior vena cava (ivc) filter, retrieval of fractured filter struts, a noncontrast cone beam computed tomography scan and abdominal aortography.The indication for the procedure was filter migration and an embolized strut embedded in the right ventricle.Using an excimer laser sheath the filter was retrieved through the jugular approach.Fluoroscopic images demonstrated embedded fractured struts within the intrahepatic ivc, all but two struts were retrieved with rigid forceps.Additional imaging was performed and demonstrated an embolized strut in a pulmonary artery position.Attempts to retrieve the strut were unsuccessful and further imaging noted that the strut was in the abdominal aorta.The strut was ultimately retrieved via access from the right femoral artery.It was noted that a right to left intracardiac shunt may be present due to the strut migrating from the pulmonary artery to the aorta.Further workup was recommended.The following week the patient underwent removal of a right ventricular foreign body via ventriculotomy, repair of the right ventricle, primary closure of secundum atrial septal defect and pulmonary vein isolation and left atrial appendage ligation.
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Manufacturer Narrative
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After further review of additional information received, the following sections have been updated accordingly: b4, b5, g4, g7, h1 and h2.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.
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Event Description
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Additional medical records for this patient state that approximately six years and eleven months after the index procedure and six months after the filter was explanted, the patient underwent a chest x-ray for weakness and head pressure.The results of the exam noted no acute intrathoracic process.The patient also underwent a computed tomography (ct) scan of the head and no acute intracranial abnormality was noted.Approximately eight years and one week after the index procedure and one year and seven months after the filter was removed, the patient underwent an x-ray of the right shoulder for complaints of pain after a fall.Results of the radiology reading noted no fracture or significant arthritis.Approximately eight years and three months after the index procedure and one year and ten months after the device was explanted, the patient presented to the emergency room (er) for complaints of left wrist pain.The patient was diagnosed with a pinched nerve and discharged.Approximately eight years and four months after the index procedure and approximately two years after the filter was removed, the patient underwent a venous duplex exam for complaints of left lower leg pain.Results of the scan determined no evidence of deep vein thrombosis (dvt).Approximately eight years and eight months after the index procedure and two years and four months after the filter was explanted, the patient underwent an x-ray of sinuses for unspecified disorder of nose and nasal sinuses.Results of the scan did not reveal any evidence of sinusitis.
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Manufacturer Narrative
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It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused inferior vena cava (ivc) perforation, filter fracture, migration and perforation of a fractured strut to the right atrium resulting in severe tachycardia and syncope.The patient¿s history is noted for thrombus within the abdominal vessels, abnormality of the ivc, a total abdominal hysterectomy, chronic renal disease (crd), menopausal symptoms successfully treated with effexor, motor vehicle accident, chest pain, shortness of breath, patent foramen ovale, fracture of the right wrist with altered consciousness secondary to trauma, cervical spine degenerative changes, arthritis, migraines, angioedema, supraventricular tachycardia, extended abdominoplasty, remote history of breast mass excision, recurrent paroxysmal atrial fibrillation (afib), diabetes, gastroesophageal reflux disease, essential hypertension (htn), thyroid nodules, and abnormal pap smear, gait disturbance, ataxia, syncope with falls, and anxiety.During evaluation of the kidneys via ultrasound for hypertension, a large plug of thrombus was identified in the ivc from the level of the iliac veins to the level of the renal veins.No deep vein thrombosis was identified during evaluation.The indication for the filter implant was free-floating, 8cm x 2cm thrombus within the ivc.The filter was placed via the left internal jugular vein and deployed several centimeters superior to the renal veins.The patient tolerated the procedure well.Approximately five years post implant the patient had a magnetic resonance venography (mrv) of the pelvis that revealed thrombosis in the ivc and that the filter had migrated into the intra-hepatic vena cava.It was also noted that several filter tines were seen extending beyond the wall of the ivc, however no hemorrhage was noted.Also, at this time, the patient was having recurrent cardiac arrhythmias.Imaging the following year revealed a filter strut within the right ventricular chamber, trapped between the myocardium and the trabeculae.The patient was considered high risk for removal surgery, so it was decided to observe and treat conservatively.Later that year, the patient went to an interventional radiology (ir) specialist for consult on percutaneous filter removal.A computerized tomography (ct) angio of the thoracic aorta with ecg showed the fractured ivc filter had migrated and now lies in the inferior vena cava at its course through the liver, above the drainage of the right and left renal veins.Atria was dilated without filling defects.Linear metallic density is noted along the posterior wall of the right ventricle, with one end abutting the myocardium and the other end tangled within the chamber trabeculae.Neither end pointed towards the right ventricle (rv) cavity.Struts measured approximately 1cm in length.A percutaneous removal of the ivc filter using laser excimer assist was successfully done.However, two small fragments remained, probably embedded in the vena cava wall or potentially extra caval.They were unable to retrieve a fragment from the pulmonary artery; however, during the attempt to retrieve this, the strut migrated to the abdominal aorta through an open atrial-septal defect, where it was successfully retrieved.There was no vena caval thrombosis noted.Ct imaging after removal identified the strut still in position in the right ventricle.The patient recovered and was discharged home with the plan to do open heart removal of the remaining strut as well as treatment for atrial fibrillation.The patient returned to the hospital and underwent an open ventriculotomy with removal of filter strut, repair of rv and closure of atrial septal defect, pulmonary vein isolation and ligation of the left atrial appendage (to treat the afib).The patient was started back on anticoagulation therapy after the post-operative course.Since restarting on anti-coagulants, the patient has experienced gastric bleeding.The patient also developed keloid scarring after the thoracic surgery.The medical records state that after implantation of the device, the patient has experienced periods of wenkenback (possibly related to the embolized struts in the right ventricle).After the device was explanted, the patient experienced anxiety, shortness of breath (lungs were clear with no wheezing, symptom resolved) and after re-starting anticoagulation therapy the patient experienced gastrointestinal bleeding from diverticulitis.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 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.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.The ifu also states filter fracture with perforation 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 was reported that there was perforation of the ivc and other structures.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Blood clots and occlusive thrombosis within the filter and vasculature and arrythmias do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel 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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