Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately 8 years post filter deployment, computed tomography revealed there was a significant tilt to the right.Coronal images showed a 16 degrees tilt.Sagittal images showed 3 degrees tilt.There was grade 3 perforation noted.Left lateral strut abuts aorta (8mm), left lateral strut abuts right common iliac artery, posterior struts abut in vertebral (4mm), right posterior strut abuts right psoas muscle (9mm), ventral strut abuts duodenum (6mm).Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter tilt.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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