The product was not returned for inspection.As reported through the legal department, the plaintiff 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 plaintiff has suffered life-threatening injuries and damages and requires extensive medical care and treatment.The plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.No additional information is available at this time.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.Vena cava thrombus or thrombus in the filter does not represent a device malfunction.The reported retrieval difficulty could not be confirmed without procedural films for review.The instructions for use note that ¿retrieval of the filter should not be attempted if thrombus is present in the filter and/or caudal to the filter.¿ 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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As reported through the legal department (b)(6), the plaintiff underwent placement of a 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 plaintiff has suffered life-threatening injuries and damages and requires extensive medical care and treatment.The plaintiff has suffered and will continue to suffer significant medical expenses, extreme pain and suffering, loss of enjoyment of life, disability, and other losses.No additional information is available.
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