(b)(4).A review of the manufacturing records for the devices verified the lots met all pre-release specifications.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 improper component placement and occlusion.
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The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses featuring c3® delivery system.A trunk-ipsilateral leg component was deployed, then repositioned to preserve an accessory renal artery on the left.This device was deployed too low, inadvertently, compromising proximal seal, and was attempted to be repositioned, but could not be repositioned.The remainder of the device was deployed fully and the gore® excluder® aaa endoprosthesis contralateral leg component was also deployed.To address the low deployment of the gore® excluder® aaa endoprosthesis trunk-ipsilateral leg component, a gore® excluder® aaa endoprosthesis aortic extender was deployed.However, it was reportedly partially impinging upon the ostium of the right renal artery.An omnilink stent was deployed in the right renal artery.The patient tolerated the procedure.On (b)(6) 2018 the patient was doing well.
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