The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the alleged perforation of the inferior vena cava (ivc) and filter malposition as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based on the available information, the definitive root cause is unknown.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: 08/2012).
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It was reported through the litigation process, approximately eight years and ten months post filter deployment, a computed tomography revealed that the filter malpositioned and struts perforated the vena cava wall and into the mid aorta.The patient experienced pain in the area of the filter; however, the current status of the patient is unknown.
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