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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Patient experienced abdominal pain.Approximately two years and three months post filter deployment, computed tomography revealed some of the filter struts have penetrated through the wall of the inferior vena cava into the mesenteric fat.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).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: 05/2018).
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It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure.At some time post filter deployment, it was alleged that the filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient experienced abdominal pain; however, the current status of the patient is unknown.
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