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 six years and six months later, a computed tomography of abdomen was performed for management of migrated inferior vena cava filter and associated aortic mural wall thrombus related to blue toe syndrome.The study showed there was stable positioning of an infrarenal inferior vena cava filter with several of its tines extending well beyond the confines of the vascular wall including one of the medial tines protruding beyond the inferior vena cava lumen eroding into the aorta with associated asymmetric mural wall thrombus and 0.7 cm pseudoaneurysm involving the anterior wall of the aorta just below the inferior mesenteric artery takeoff.These were unquestionably the source of the patient¿s embolism and blue toe.However, the patient¿s history revealed that one of the prior computed tomographic studies also showed that the inferior vena cava filter had migrated into the infrarenal aorta and there was a small aortic pseudoaneurysm at the site of the strut perforation due to which repeated abdominal computed tomography was obtained on the present day.Lengthy discussions were made regarding a variety of surgical options including an exploratory laparotomy with inferior vena cava and aortic repair with filter explant.Based on the overall presentation, isolation of the symptoms from the filter to an aortic repair and magnitude of an open operation as well as filter explant, it was recommended to undergo aortic stent graft placement to exclude the aortic pseudoaneurysm and thrombus, as well as malpositioned filter tine.After one month, a computed tomography of abdomen and pelvis was performed.The study showed that an abdominal aorta demonstrated interval placement of an endovascular stent graft in the infra-abdominal aorta near the inferior vena cava filter struts and one strut was still appeared adjacent to the graft.The study also showed an inferior vena cava filter with penetration of the struts.After seven months, a computed tomography of abdomen and pelvis was performed.The study showed a stable appearance of the endovascular stent graft in the infrarenal abdominal aorta adjacent to the filter and an inferior vena cava filter was again seen with the penetration of the struts like prior examinations.Also, one of the struts again appeared adjacent to the aortic endovascular stent graft.Therefore, the investigation is confirmed for the alleged filter migration and 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.(expiry date: 02/2011).
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