Manufacturing review: 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.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately six months later post filter deployment, the patient experienced abdominal pain, computed tomography scan of abdomen and pelvis without contrast was performed which showed inferior vena cava filter was present.After three years and five months, computed tomography scan of abdomen with contrast was performed which showed occlusion of the inferior vena cava at the level of the filter.After one year and ten months, the patient experienced right upper quadrant abdominal pain, computed tomography scan of abdomen and pelvis with contrast was performed which showed inferior vena cava was in place.After five months, computed tomography scan of abdomen and pelvis with contrast was performed which showed inferior vena cava filter with proximal projecting beyond contour of the vessel.Infra renal inferior vena cava was small which was suggestive of chronic occlusion; bilateral iliac vessels are also small.Therefore, the investigation is confirmed for the alleged filter occlusion and perforation of the inferior vena cava.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: 03/2014).
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