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 four years and 15days post filter deployment, computed tomography revealed no pulmonary embolism.After 1 month and 1 day, the patient presented with abdominal pain.After 7 months and 18 days, the patient presented with abdominal pain.After 10 months and 18 days, computed tomography revealed the legs of the filter had penetrated through the wall of the inferior vena cava into the pericaval/mesenteric fat.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc).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: 08/2018).
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It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with left lower extremity deep vein thrombosis and in conjunction before upcoming surgery.Approximately one year and eleven months post filter deployment, a computed tomography (ct) abdomen without contrast revealed that the filter legs perforated the inferior vena cava into the pericaval/mesenteric fat.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.
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