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 seven years and ten months post filter deployment, computed tomography revealed the filter perforated the caval walls.One prong indent upon aorta and another prong imbedded into the l3 vertebral body, soft tissue and osseous structures.The patient experienced abdominal pain.Eventually one year and three months later, computed tomography revealed the filter was in the inferior vena cava which was significantly tilted to the right at approximately 26 degrees and slightly tilted anteriorly evaluated in the sagittal plane.Several proximal struts appeared patent and many extended beyond the walls of the inferior vena cava.Two posterior right struts abutted the vertebral body.One of the anterior left struts comes in close proximity to the wall of the aorta.Another anterior left strut comes in close proximity to an unopacified small bowel loop.Therefore, the investigation is confirmed for the perforation of 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: 03/2012).
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