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 after four years and three months a computed tomography (ct) shows the apex of the filter was approximately 3 cm inferior to the origin of the renal veins.The apex of the filter was tilted to the right, that abutted the right lateral wall of the inferior vena cava.There were multiple legs of the inferior vena cava filter which had penetrated through the wall of the inferior vena cava, greatest along the left margin of the inferior vena cava, the legs of the inferior vena cava filter contacted the anterior aspect of the l4 vertebral body.Legs of the filter abutted above the right lateral wall of the abdominal aorta.Approximately after three years later, computed tomography (ct) shows tip of the filter was tilted to the right and it was below the renal veins.At least one strut appeared to penetrate the medial wall and abutted the aorta.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) filter and filter tilt.However the investigation is inconclusive for the 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.(expiry date: 05/2014).
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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, migrated and struts perforated the anterior aspect of the l4 vertebral body and abuts the wall of the distal abdominal aorta.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced severe pain at the result of struts perforated through the inferior vena cava and at the left lateral aspect; however, the current status of the patient is unknown.
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