Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately eleven months of post deployment, the patient had back pain.Approximately four years and six months later, computed tomography showed complete thrombosis of bilateral ileofemoral veins extending into the inferior vena cava upto the filter.Thrombus cephalad to the inferior vena cava filter was noted and the retrohepatic inferior vena cava was patent.It was stated that the thrombus was possibly provoked deep vein thrombosis from inferior vena cava filter placed five years and three months earlier.On the same date, the patient had back and chest pain.Three days later, computed tomography of abdomen and pelvis was positive for complete thrombosis of ileofemoral veins bilaterally extending into the inferior vena cava upto an infrarenal inferior vena cava filter.Computed tomography revealed inferior vena cava thrombosis below and above inferior vena cava filter.Two days later, venogram showed greater than 60 percent lysis post successful thrombectomy and mild residual inferior vena cava filter clot was noted.Twenty-five days later, inferior vena cava filter was in place.Approximately ten years and two months later, the patient had abdominal pain and computed tomography of abdomen without contrast revealed significant narrowing involving a 3 cm length of the infrarenal inferior vena cava extending from the inferior vena cava filter legs to the origins of the bilateral common iliac venous stents with numerous large anterior abdominal wall collaterals consistent with chronic inferior vena cava occlusion/thrombosis.Many of the inferior vena cava filter legs extended beyond the expected lumen of the inferior vena cava.Therefore, the investigation is confirmed for perforation of the inferior vena cava.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.
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