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Model Number 466FXXXX |
Device Problem
Break (1069)
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Patient Problems
Perforation (2001); Perforation of Vessels (2135)
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Event Date 07/29/2019 |
Event Type
Injury
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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 all six prongs are against or have perforated the aortic wall.The indication for the filter implant, procedural details and medical history of the patient have not been provided and there is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The 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.Perforation of the ivc was reported, however a clinical conclusion could not be determined as to the cause of the event.Without post implant images for review, the reported filter perforation of the aortic wall could not be confirmed or further clarified.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications associated with ivc filters.Given the limited information currently available for review, 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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As reported in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to all six prongs are against or have perforated the aortic wall.
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Event Description
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As reported in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to all six prongs are against or have perforated the aortic wall.According to the medical records, four days prior the index procedure, the patient presented to the emergency room with symptoms of a cerebrovascular accident (cva).The patient was also noted to have trouble controlling the blood pressure in the past.A computerized tomography (ct) scan found acute hemorrhage of the right thalamus with possible old basal ganglia infarct.The patient's medical history included type ii diabetes and hypertension, chronic kidney disease stage 3, hepatic steatosis, chronic alcoholism, obesity, hyperlipidemia, back surgery and hernia repair.Per the implant records, the patient was reported to have a preoperative diagnosis of deep vein thrombosis (dvt) and pulmonary (pe) embolism with contraindication anticoagulation.Ultrasonography was used to interrogate the right groin, not able to visualize the femoral venous system well; however, the left the femoral venous system was easily interrogated.Using ultrasound guidance, percutaneous access to the common femoral vein was obtained and a guidewire passed into the inferior vena cava.The vena cavogram sheath was passed to l2 mid body.The right renal vein at the inferior border at the l1 was localized.The optease filter was positioned with its hook down at the inferior border of l1 and deployed.The vena cava measured less than 2.5cm in diameter.The filter seated nicely.The patient tolerated the procedure well and was transferred back to his room in stable condition.Approximately two years and five months after the filter was implanted, an abdominal ct scan reported the presence of a ¿birdcage¿ type inferior vena cava filter, that may represent a ¿bart ivc filter¿ and correlates with procedural history.The superior tip of the filter is located just below the right renal vein and the inferior tip of the filter is located above the iliac vein confluence by about 2cm.The inferior vena cava (ivc) filter has six prongs, all locating against or in the aortic wall.No discrete breakage of the ivc filter.No discrete area of ivc filter prongs extension beyond the confine of the aortic wall.No hematoma or fat stranding/inflammation around the inferior vena cava, particularly at the level of the filter.A small hyperdense cyst in the right upper renal cortex, and small pericardial effusion were also visualized.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc and perforation of filter struts into organs.The patient further experienced anxiety and fear related to the filter causing further damage as it has not been safely removed and became aware of the reported events approximately two years and five months after the filter implantation.
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Manufacturer Narrative
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Section d6 (implant date) was updated.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 all six prongs to have perforated the aortic wall.The patient reported becoming aware of perforation of filter struts outside the ivc and perforation of filter struts into organs approximately two years and five months post implant.The patient also reported anxiety and fear related to the filter.According to the medical records, four days prior the index procedure, the patient presented to the emergency room with symptoms of a cerebrovascular accident (cva).The patient was also noted to have trouble controlling the blood pressure in the past.A computerized tomography (ct) scan found acute hemorrhage of the right thalamus with possible old basal ganglia infarct.The patient's medical history included type ii diabetes and hypertension, chronic kidney disease stage 3, hepatic steatosis, chronic alcoholism, obesity, hyperlipidemia, back surgery and hernia repair.According to the implant record the indication for the filter implant was deep vein thrombosis (dvt) and pulmonary (pe) embolism with contraindication to anticoagulation.The filter was placed via the left common femoral vein and deployed with the hook down at the inferior border of l1.The patient tolerated the procedure well.Approximately two years and five months post implant, an abdominal ct scan reported the presence of a ¿birdcage¿ type ivc, that may represent a ¿bart ivc filter¿.The superior tip of the filter is located just below the right renal vein and the inferior tip of the filter is located above the iliac vein confluence by about 2cm.The ivc filter has six prongs, all locating against or in the aortic wall.No discrete breakage of the ivc filter.No discrete area of ivc filter prongs extension beyond the confine of the aortic wall.No hematoma or fat stranding/inflammation around the inferior vena cava, particularly at the level of the filter.There is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The 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.Perforation of the ivc was reported, however a clinical conclusion could not be determined as to the cause of the event.Without post implant images for review, the reported filter perforation of the aortic wall and organs could not be confirmed or further clarified.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications associated with ivc filters.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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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Search Alerts/Recalls
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