(b)(4).According to the gore® excluder® endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to aneurysm enlargement and endoleak.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) 2015 - the date of aneurysm enlargement.
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On (b)(6) 2014, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 57.9 mm in diameter, and was implanted with gore® excluder® endoprostheses.The patient tolerated the procedure.It was reported that on (b)(6) 2017, a type ii endoleak was identified and the patient underwent coil embolization procedure.No further adverse events have been reported.From (b)(6) 2015 till (b)(6) 2017, the aneurysm size measured from 60 mm to 43 mm.
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