The following sections have been updated accordingly.As reported, the filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: abundant serpiginous superficial abdominal and chest collaterals probably due to inferior vena cava (ivc) blockage, total occlusion and tachycardia leading to a diagnosis of post-thrombotic syndrome.In addition, bilateral deep vein thrombosis (dvts) and chronic thrombosis of the inferior vena cava (ivc) requiring the placement of wall stents over the filter, down to the iliac vein due to chronic eccentric thrombus within the filter.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.The inferior vena cava (ivc) 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.Deep vein thrombosis (dvt) occurs when a blood clot forms in a deep vein and is most common in the deep veins of the lower leg (calf), and can spread up to the veins in the thigh.Placement of a vena cava filter is not a cure for dvt nor does it prevent the formation of dvt or other clots (thrombosis).Post thrombotic syndrome is a problem that can develop in nearly half of all patients who experience a dvt.Per the legal briefing, the ivc occlusion and tachycardia occurred as a result of this post thrombotic syndrome.The brief mentioned collateral circulation due to inferior vena cava blockage.Collateral circulation is the circulation of blood established through enlargement of minor vessels and anastomosis of vessels with those adjacent parts when a major vein or artery is functionally impaired.Blood clots within the device do not represent a device malfunction.Blood clots and occlusion of the ivc or the device does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation 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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The following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) filter to protect against subsequent pulmonary embolus (pe) since patient was found to have developed bilateral deep vein thrombosis (dvt) and a large pe.The patient also had a history of having a large abdominal mass which was causing vena caval and iliac vein compression.During placement of the filter via the right internal jugular, the filter was successfully deployed and in good position at approximately the level of across the l2 vertebral body and onto the l1 vertebral artery, below the level of the left renal vein.The patient tolerated the procedure well.According to the information received in the patient profile from (ppf), the patient became aware of the alleged events sometime post implantation and reports to suffer from blood clots, clotting, and/or occlusion of the ivc, the device being unable to be retrieved, post-thrombotic syndrome, and being on long term anticoagulant therapy.However, no known attempted filter retrieval attempts have been made.The patient states to have experienced emotional and physical pain and suffering.The patient reports to having massive clotting in both lower extremities, inability to walk unassisted, the inability to provide themselves with basic personal hygiene, nerve damage, significant swelling in lower extremities, weight gain, total occlusion of filter, requiring angioplasty and multiple stent placements from the ivc to the iliac veins.Approximately on or about eleven years and four months post implantation, the patient underwent a computerized tomography (ct) scan that showed total occlusion of the ivc and the patient was also diagnosed with tachycardia.Approximately a month later, the patient was diagnosed with chronic thrombosis of the ivc, post thrombotic syndrome, and chronic vein insufficiency, due to the massive clotting over years of filter blockage.Approximately four months after, the patient reports to having been implanted with ten wall stents above and below the ivc filter to deal with the stenosis.The patient was then diagnosed with chronic bilateral lower dvt extending from the external iliac vein to the level of the ivc filter bilaterally.The patient states to continue to worry and be in fear about all the possible complications that the filer can cause.The patient also reports poor circulation of the lower extremities due to blockage at the ivc filter, having to be aided in every aspect of their life that takes walking or movement from the waist down.The patient states to have lost the ability to be intimate, to deal with constant pain, cramping, and swelling from the ivc filter through their lower extremities.Also, the patient can not participate in many of their hobbies and are depressed and lonely.Patient code '3191' was used since no available code for chronic venous insufficiency.As reported, the patient had implantation of an unknown cordis inferior vena cava (ivc) filter.Per the medical records, the patient underwent placement of the inferior vena cava (ivc) filter to protect against subsequent pulmonary embolus (pe) since patient was found to have developed bilateral deep vein thrombosis (dvt) and a large pe.The patient history includes large abdominal mass causing vena caval and iliac vein compression.During placement of the filter via the right internal jugular, the filter was successfully deployed and in good position at approximately the level of across the l2 vertebral body and onto the l1 vertebral artery, below the level of the left renal vein.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: abundant serpiginous superficial abdominal and chest collaterals probably due to inferior vena cava (ivc) blockage, total occlusion and tachycardia leading to a diagnosis of post-thrombotic syndrome.In addition, bilateral deep vein thrombosis (dvts) and chronic thrombosis of the inferior vena cava (ivc) requiring the placement of wall stents over the filter, down to the iliac vein due to chronic eccentric thrombus within the filter.Per the patient profile from (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc, the device being unable to be retrieved, post-thrombotic syndrome, and being on long term anticoagulant therapy.However, no known attempted filter retrieval attempts have been made.The patient reports emotional and physical pain and suffering, massive clotting in both lower extremities, inability to walk unassisted, the inability to complete personal hygiene, nerve damage, significant swelling in lower extremities, weight gain, total occlusion of filter, requiring angioplasty and multiple stent placements from the ivc to the iliac veins.Approximately eleven years and four months post implantation, the patient had a ct scan that showed total occlusion of the ivc and the patient was also diagnosed with tachycardia.Approximately a month later, the patient was diagnosed with chronic thrombosis of the ivc, post thrombotic syndrome, and chronic vein insufficiency, due to the massive clotting over years of filter blockage.Approximately four months after, the patient reports to having been implanted with ten wall stents above and below the ivc filter to deal with the stenosis.The patient was then diagnosed with chronic bilateral lower dvt extending from the external iliac vein to the level of the ivc filter bilaterally.The patient reports worry and fear.The patient reports the inability to be intimate, constant pain, cramping, and swelling from the ivc filter through their lower extremities.Also, the patient reports depression.The filter remains implanted; thus, unavailable for analysis.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 cordis 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, post thrombotic syndrome and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Stenosis 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.Collateral circulation and chronic venous insufficiency do not represent a device malfunction and may be related to underlying patient related issues.Tachycardia, anxiety, nerve damage, weight gain, loss of personal independence in daily activities 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.Clinical factors that may have influenced the event include patient, specifically the history of thrombosis, 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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