Per the gore¿ excluder¿ iliac branch endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, occlusion of device or native vessel.
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On (b)(6) 2020, a patient underwent endovascular treatment of a right common iliac artery aneurysm using gore¿ excluder¿ aaa and iliac branch endoprostheses.An iliac branch component was implanted on the right side, and two internal iliac components were implanted in the right internal iliac artery.The patient tolerated the procedure.On an unknown date in (b)(6) 2020, the patient presented for follow-up examination with buttock pain.A computed tomography scan was performed, and thrombus occlusion of the internal iliac components was reportedly observed.The physician suspected that a contralateral limb used as a bridging device during the procedure may have been deployed at a slant, which may have partially obstructed the proximal end of the internal iliac component.No treatment was performed for the occlusion, and the physician will continue to monitor the patient.
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