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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately six years and seven months of post deployment, computed tomography of abdomen was performed for filter evaluation.The study showed that inferior vena cava filter was in place just below the level of renal veins.Images of the inferior vena cava demonstrated no break.An arm of the inferior vena cava filter extends through the medial wall and abuts the abdominal aorta.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc).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: 07/2014).
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