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 seven months later a computed tomography reveled about pulmonary embolic disease.The findings were compatible with pulmonary embolic disease involving the segmental branches of right upper lobe, right lower lobe as well as left lower lobe, a x-ray shows that the inferior vena cava filter was in place with tip at the mid vertebral level and legs at the mid vertebral level.Previously, the tip of the filter projected at the disc space level.The filter appears to have migrated slightly inferiorly since the comparison plain film.Therefore, the investigation is confirmed for filter migration.Additionally, it can be confirmed that the patient experienced pulmonary embolism 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: 08/2013).
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It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter migrated.The device has not been removed and there were no reported attempts to retrieve the filter.The patient was diagnosed with pulmonary embolism post filter implant; however, the current status of the patient is unknown.
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