Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, history includes recurrent bilateral pulmonary embolism with left lower extremity deep vein thrombosis and edema, multiple sclerosis, urinary tract infections, gastroesophageal reflux disease, anxiety and depressive disorder.The filter was deployed without incident.The patient tolerated the procedure well.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to post implant occlusion of inferior vena cava (ivc) followed by a complicated removal procedure.Per the patient profile form (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc.Nine years and eight months after implant, the device was removed.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 trapease 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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, 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.Please note that this is the initial/final report for this product.
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As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to post implant occlusion of inferior vena cava (ivc) followed by a complicated removal procedure.The medical records indicate that the patient has a history of left lower extremity edema, recurrent bilateral pulmonary embolism with left lower extremity deep vein thrombosis, multiple sclerosis, urinary tract infections and gastroesophageal reflux disease, anxiety and depressive disorder.The filter was deployed without incident.The patient tolerated the procedure well. the patient profile form (ppf) states that the patient experienced blood clots, clotting, and/or occlusion of the ivc.The patient became aware of the reported events nine years and eight months after the index procedure when the device was removed.While the device was implanted, the patient experienced anxiety.
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