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, eight months of post deployment, the patient with abdominal pain underwent a computed tomography abdomen scan.It was revealed that an inferior vena cava filter was seen with its cephalad most portion projecting at the level of inferior endplate of l3.The umbrella was angled with its most superior margin abutting the intima of the inferior vena cava on the right.The caudally located filter struts projected through the lumen of the inferior vena cava into the into the retroperitoneum on the left.There appeared to be at least 2-3 struts projecting intraluminally.An anterior strut appeared to project from the inferior vena cava into the right common iliac artery proximally.There was no retroperitoneal hematoma.Therefore, the investigation is confirmed for perforation of the inferior vena cava (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: 11/2012).
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