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 seven years and two months post filter deployment, patient presented with abdominal pain.Approximately five years later, computed tomography revealed inferior vena cava filter below the renal veins.The lines tent the inferior vena cava, there was apparent extent of the inferior vena cava tines beyond the margin of the inferior vena cava wall.There was no erosion into the aorta, no erosion of the tines into the bowel.On the coronal view, the tilt was measured at seven degrees with respect of the center of the inferior vena cava filter axis, the tip was toward the right.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).However, the investigation is unconfirmed for filter tilt as the medical record states ¿on the coronal view, the tilt was measured at seven degrees with respect of the center of the inferior vena cava filter axis, the tip was toward the right¿.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: 01/2013.
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