Additional manufacturer narrative: review of the manufacturing records could not be performed as no lot number information was provided.The device was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.All information has been placed on file for use in tracking and trending.
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Published abstract "two-year evaluation of fenestrated and parallel branch endografts for the treatment of juxtarenal, suprarenal,and thoracoabdominal aneurysms at a single institution" (mohsen bannazadeh, m.D., william e.Beckerman, m.D., adam h.Korayem, m.D., and james f.Mckinsey, m.D., new york, ny; copyright 2019 published by elsevier inc.On behalf of the society for vascular surgery; https://doi.Org/10.1016/j.Jvs.2019.03.058) was reviewed.The abstract discusses the mortality, graft patency, renal function, complication, and reintervention rates for fenestrated and parallel endografts in complex aortic aneurysms repairs from august 2014 to march 2017 in a single center.The abstract reported in the reintervention, branch reintervention, and endoleaks section under the fenestrated group identified 2 type iii endoleaks and 1 gutter endoleak.
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Date of event - date of event is an estimate based on the date of presentation at the forty-first annual meeting of the midwestern vascular surgical society, chicago, ill.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.The article indicated both gore® viabahn® vbx balloon expandable endoprosthesis & gore® viabahn® endoprosthesis were involved.However, the article did not provide specifics.Reference mdr #2017233-2020-00029 for gore® viabahn® vbx balloon expandable endoprosthesis report.
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