Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately nine year and eight months post filter deployment, computed tomography shows the filter located at the level of l1.The tip of the filter was below the level of the renal veins and the apex of touched the right anterior wall of the inferior vena cava.The filter struts appeared to extend beyond the inferior vena cava wall.Two of the filter struts appeared to abut the abdominal aorta wall.Therefore, the investigation is confirmed for perforation of ivc.However the investigation is inconclusive for filter tilt, as there is no objective evidence to confirm 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: 06/2010).
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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 wall of the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient experienced pain in area where filter was placed; however, the current status of the patient is unknown.
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