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.Completion venogram showed the satisfactory position of the filter distal to the renal vein.Approximately three years and six months post filter deployment, the patient presented with an inferior vena cava filter and pain.Subsequently on the same day, computed tomography (ct) revealed that there was an inferior vena cava filter, just below the more inferior right renal vein.The apex of the inferior vena cava filter was tilted anteriorly.The struts of the inferior vena cava filter were intact.There was slight extension of the struts beyond the wall of the inferior vena cava filter, which was most pronounced in the right anterior strut that measured 2 mm beyond the wall.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter tilt.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: 04/2018).
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It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that filter tilted and struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.
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