As reported in the legal brief (b)(6), after an unknown period of time the plaintiff subsequently developed extensive inferior vena cava filter thrombosis.Approximately 4 years after the device was implanted, the plaintiff expired due to multiple organ failure resulting from obstructive shock caused by inferior vena cava filter thrombosis.An additional legal brief indicates the filter subsequently malfunctioned and caused great bodily harm to the plaintiff including, but not limited to, caval thrombosis, pe, and dvt.As direct and proximate results of these filter malfunctions, the plaintiff suffered fatal injuries, damages, and untimely death on or about (b)(6) 2014.
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As reported in the legal brief, after an unknown period of time following implantation of an optease filter, the plaintiff subsequently developed extensive inferior vena cava filter thrombosis.Approximately 4 years after the device was implanted, the plaintiff expired due to multiple organ failure resulting from obstructive shock caused by inferior vena cava filter thrombosis.An additional legal brief indicates the filter subsequently malfunctioned and caused great bodily harm to the plaintiff including, but not limited to, caval thrombosis, pe, and dvt.As direct and proximate results of these filter malfunctions, the plaintiff suffered fatal injuries, damages, and untimely death on or about (b)(6) 2014.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 (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.Pulmonary embolism, deep vein thrombosis and vena cava thrombus do not represent a device malfunction.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.Large thrombus within the vena cava or lower extremities may impede perfusion contributing to organ dysfunction.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.
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