The 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.It is unclear if the implanted device was gore® viabahn® vbx balloon expandable endoprosthesis or gore® viabahn® endoprosthesis (ref medwatch #2017233-2020-00023).
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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 mortality and survival section a patient developed mesenteric ischemia as a result of celiac artery thrombosis likely owing to incomplete collateral circulation between the celiac artery and the sma.The patient presented with elevated liver enzymes and postoperative day 1 with subsequent rapid deterioration and multiorgan failure despite celiac artery revascularization on postoperative day 1.It is unclear if the implanted device was gore® viabahn® vbx balloon expandable endoprosthesis or gore® viabahn® endoprosthesis.
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