Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately three years and four months post filter deployment, a computed tomography angio (cta) chest was performed and it revealed there was a filling defect within the distal branch of the right lower lobe pulmonary artery.The remainder of the pulmonary arteries appear well-opacified without additional filling defect.Subsequent iliac venogram was performed and it revealed the right iliac vein and inferior vena cava to be widely patent.However, the partially expanded inferior vena cava filter appears to be within a small paravertebral venous branch of the right iliac vein, rather than the inferior vena cava.Therefore, the investigation is confirmed for alleged failure to expand.Additionally, it can be confirmed that the patient experienced pe post deployment.However, the relationship to the filter is unknown.Based on the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.(expiry date: 10/2015).
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