Manufacturing review: the device history records have been reviewed and 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 three years and six-month post filter deployment, computed tomography (ct) revealed that the filter to be in good position with the tip located 19 mm below the renal vein and there was approximately 8 degrees of tilt to the right relative to the course of the inferior vena cava.There was a single strut inferior and to the left and posterior appears to penetrate the inferior vena cava wall of approximately 3 mm and located within the fat and does not contact or penetrate any other structures.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).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 (07/2015).
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