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Catalog Number 466F220A |
Device Problems
Fracture (1260); Difficult to Remove (1528)
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Patient Problems
Occlusion (1984); Thrombosis (2100)
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Event Date 08/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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It was reported that a patient underwent placement of an optease retrievable vena cava filter (ivc).The indication for the placement was heavy uterine bleeding, requiring surgery and a history pulmonary embolus for which the patient was on coumadin.The filter was successfully placed below the infrarenal ivc without immediate complications.According to the information received, the device, inter alia, caused a large thrombus of the vena cava and filter and is irretrievable.As a result of the malfunction, the patient has suffered life-threatening injuries and damages and requires extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.The following additional information contained on the patient profile from (ppf) indicated that the patient had blood clots, clotting and occlusion of the inferior vena cava (ivc).Twenty-two days post implantation, the patient underwent an unsuccessful attempt to remove the filter percutaneously.Twenty-eight days after that, the patient underwent another unsuccessful filter removal attempt.The patient also reports to be suffering from persistent anxiety and panic.There is currently no additional information available.The product was not returned for analysis as it remains implanted.A review of the device history record (dhr) associated with lot 15300299 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 optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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 the procedural films or post implant images to review the reported retrieval difficulty could not be confirmed.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.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.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, resulting in extremity edema.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, it is not possible to determine what factors may have contributed to the reported information, nor is there anything to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.This report is a follow up report to mfr number 9616099-2016-00336 that was submitted under the previous complaint handling software system.The information has been duplicated from the first report with additional information added.
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Event Description
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As reported by the legal brief, the patient underwent placement of an optease retrievable vena cava filter.The device, inter alia, caused a large thrombus of the vena cava and filter and is irretrievable.As a result of the malfunction, the patient has suffered life-threatening injuries and damages and requires extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.The following additional information received per the patient profile from (ppf) indicates that the patient had blood clots, clotting and occlusion of the inferior vena cava (ivc).Twenty-two days post implantation, the patient underwent an unsuccessful attempt to remove the filter percutaneously.Twenty-eight days after that, the patient underwent another unsuccessful filter removal attempt.The patient also reports to be suffering from persistent anxiety and panic.According to the medical records, the patient had a history of heavy uterine bleeding while on coumadin for pulmonary emboli (pe).The filter was implanted prior to a surgery as the patient was unable to be anticoagulated.The filter was successfully placed below the infrarenal ivc without immediate complications.
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Manufacturer Narrative
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It was reported that a patient underwent placement of an optease vena cava filter (ivc).The indication for the placement was heavy uterine bleeding, requiring surgery and a history of pulmonary embolus for which the patient was on coumadin.The filter was successfully placed below the infrarenal ivc without immediate complications.It was reported that the device caused a large thrombus of the vena cava and filter and is irretrievable.The patient reported blood clots, clotting and occlusion of the ivc.Twenty-two days post implant, the patient underwent an unsuccessful attempt to remove the filter percutaneously.Twenty-eight days after that, the patient underwent another unsuccessful filter removal attempt.The patient also reports persistent anxiety and panic.Additional information provided indicated that a computerized tomography (ct) scan of the abdomen performed approximately seven years post implant noted that the ivc filter was unchanged in appearance, but the possibility of a fractured strut in the midportion of the filter was noted, as compared to a ct scan from approximately a year and nine months earlier.Approximately seven years and two months post implant, a kub (kidneys, ureters, bladder) x-ray was performed.Results of the x-ray reported an ivc filter in place with the superior aspect at the l2-l3 disc space and the appearance of a fractured strut within the midportion of the filter.There is currently no additional information available for review.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.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Blood clots, clotting and/or occlusive thrombosis within the filter and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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.With the very limited information currently available for review, it is not possible to determine what factors may have contributed to the reported information, nor is there anything to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
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Event Description
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As reported by the legal brief, the patient underwent placement of an optease retrievable vena cava filter.The device, inter alia, caused a large thrombus of the vena cava and filter and is irretrievable.As a result of the malfunction, the patient has suffered life-threatening injuries and damages and requires extensive medical care and treatment.The patient has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.The following additional information received per the patient profile from (ppf) indicates that the patient had blood clots, clotting and occlusion of the inferior vena cava (ivc).Twenty-two days post implantation, the patient underwent an unsuccessful attempt to remove the filter percutaneously.Twenty-eight days after that, the patient underwent another unsuccessful filter removal attempt.The patient also reports to be suffering from persistent anxiety and panic.According to the medical records, the patient had a history of heavy uterine bleeding while on coumadin for pulmonary emboli (pe).The filter was implanted prior to a surgery as the patient was unable to be anticoagulated.The filter was successfully placed below the infrarenal ivc without immediate complications.According to the medical records provided, approximately seven years after the filter was implanted, the patient underwent an abdominal computerized tomography (ct) scan.The scan reported an ivc filter with unchanged appearance.The inferior vena cava is patent through the inferior vena cava filter with possibility of a fractured strut in the midportion of the filter.No evidence of calcified plaque in the thoracic aorta was noted.No coronary artery calcifications present, and the abdominal aorta is without calcification.No evidence of renal collecting system calcification on the left; and on the right, there is a punctate stone in the mid collecting system.Multiple bilateral noncalcified solid lung nodules were incidentally detected, and degenerative disc disease was identified in the lower lumbar spine.Results from another ct scan completed approximately a year and nine months earlier were used for comparison.Approximately seven years and two months post implantation, a kub (kidneys, ureters, bladder) x-ray indicated for the presence of other vascular implants and grafts, reported an ivc filter in place with the superior aspect at the l2-l3 disc space.There does appear to be a fractured strut within the midportion of the filter.The kub results were compared with the abdominal ct results that were reported a month prior.
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Search Alerts/Recalls
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