Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.After sometimes, a computed tomography of abdomen was performed for filter check.The study showed that inferior vena cava filter was noted.The top of the filter was just below the level of renal veins.Significant filter tilt was not obvious.The prongs at the level of 3:30 and 4:30 position, that extend most inferiorly, appear to extend beyond the wall of the inferior vena cava and abut the posterior wall of the aorta, with their tips seen on axial images extending approximately 7-8 mm beyond the wall of the inferior vena cava.The other prongs do not extend significantly beyond the wall of the inferior vena cava or at least no more than 1 mm.There was no significant collapse of the inferior vena cava below the level of the filter.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
|