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 nine years post filter deployment, ct revealed multiple legs protruding through the vena cava wall and the tip of the filter appeared to be partially obstructing the outflow of the left renal vein.Therefore, the investigation is confirmed for perforation of the ivc.However, the investigation is inconclusive for filter tilt.Based upon 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: 05/2011).
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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 tilted and embedded in the wall of ivc and struts perforated into organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.
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