Medtronic received the following information obtained from the journal article entitled; explant of aortic stent grafts following endovascular aneurysm repair e boyle, sm mchugh, a elmallah , m lynch, d mcguire, z ahmed, c canning, mp colgan, sm o¿neill, a o¿callaghan, z martin and p madhavan department of vascular surgery, st.James¿s hospital, dublin 8, ireland doi: 10.1177/1708538119832727.Exact date of event unknown.If information is provided in the future, a supplemental report will be issued.
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An endurant stent graft system was implanted in a patient for the endovascular treatment of a 55mm diameter abdominal aortic aneurysm.It was noted that the device was placed in the patient outside of ifu due to hostile neck anatomy.It was reported that patient had an explant procedure with an aorto-bi-iliac bypass due to a type ia endoleak and limb thrombosis, 54 months post index evar procedure.The patient had complication after the intervention procedure of sub-acute bowel obstruction, wound dehiscence requiring re-laparotomy and acute kidney injury.The cause of the endoleak and thrombosis is unknown but may have been related to challenging patient anatomy.No additional clinical sequelae were reported and the patient is fine.
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