Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) 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 one year and two months post filter deployment, bilateral lower extremity venogram revealed thrombotic occlusion of the ivc below the ivc filter and extending into the common iliac veins.Above the filter, the ivc is patent.Bilateral thrombolytic infusion catheters were placed and will plan for overnight thrombolysis and reevaluation in 24 hours.Subsequently, a day later bilateral iliac stents with 14x80 mm and 14x40 mm on left and 14x80 mm on right were placed successfully.Approximately three years later, ct revealed superior extent of ivc filter at mid l2 vertebral body and inferior extent at l3-l4 disc space.A total of five prongs had perforated the ivc with maximum distance of 7mm.Therefore, the investigation is confirmed for the perforation of the ivc.However, the investigation is inconclusive for the occlusion of the ivc filter.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: 02/2017).
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