The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleak and aneurysm enlargement.Users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.The date of event will be used as (b)(6) 2016 - the date of aneurysm enlargement.
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On (b)(6) 2015, this patient underwent endovascular treatment for an abdominal aortic aneurysm rupture using gore® excluder® endoprostheses.Pre-treatment ct revealed that the maximum diameter of the aortic aneurysm/lesion was 71.2mm.The patient tolerated the procedure.No complications were reported and the patient was discharged on (b)(6) 2015.Reportedly, on (b)(6) 2016, the follow up computed tomography angiography (cta) revealed a type ii endoleak originated from the inferior mesenteric artery (ima) and lumbar arteries.From (b)(6) 2016 to (b)(6) 2017 the follow up cta showed that aneurysm enlarged from 73mm to 78mm.It was reported that on (b)(6) 2017, the patient underwent an ima and lumbar arteries ligation.According to the physician, the event was not related to device or procedure.No further adverse events have been reported.The patient was discharged on (b)(6) 2017.
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