Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.See medwatch #2017233-2019-00186 for device # (b)(4).
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The following was reported to gore: on (b)(6) 2017, this patient underwent endovascular repair for iatrogenic hepatic artery injury using two gore® viabahn® endoprosthesis with heparin bioactive surface.The patient tolerated the procedure.On an unknown date (probably at least one year after the initial procedure), computed tomography was performed, however, the endoprostheses were not found in the artery.Imaging was performed from top to toe, and there were no endoprostheses found.The physician assumed that the hepatic artery adhered to and perforated the bowel, and the endoprostheses were discharged outside the body.This was only speculation but the physician considered very probable.It was reported that no clinical problem occurred.
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