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 three years and ten months post filter deployment, computed tomography (ct) revealed the inferior vena cava filter was in place.After two days later, computed tomography (ct) revealed the inferior vena cava filter was in place and the filter apex projected about 4 cm above the level of the right venal vein.There was thrombosis of the inferior vena cava at and below the level of the filter.Thrombus was also noted within both internal iliac veins as well as within the superficial femoral and profunda femoral veins.After two days later bilateral lower extremity venogram, bilateral lytic catheter placement and balloon angioplasty, right superficial femoral were done.After one day later lytic check venogram and repositioning of lytic catheter were performed and the clot in the inferior vena cava was resolved.On the same day, a recovery cone was inserted and used to capture the filter which was removed without difficulty.The option filter was placed at the level of the right renal vein.Therefore, the investigation is inconclusive for filter migration.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.
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