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 ten months later, an upper gastrointestinal study was performed for right upper quadrant abdominal pain.The study showed that normal bowel with no evidence of inflammation.After nine years, a computed tomography of abdomen was performed for filter check.The study showed that inferior vena cava filter was in distal inferior vena cava and the spindles do not appear to be broken nor do they appear to be significantly upturned.Some spindles extend to the outer edge of the inferior vena cava and may extend to the perivascular soft tissues however no other abnormality was demonstrated.Therefore, the investigation is confirmed for the alleged 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: 09/2012).
|