On (b)(6) 2019 four gore® viabahn® vbx balloon expandable endoprostheses were implanted during an endovascular aortic repair (evar).Percutaneous axillary access was gained by a down-cut.During the procedure heparin was used as antiplatelet/anticoagulant.The viabahn® vbx devices were used as bridging devices to the right renal artery, the left renal artery, the coeliac trunk and the superior mesenteric artery (4-branched evar).The study database indicates that all viabahn® vbx devices were successfully placed and deployed as intended without abnormalities noticed.All viabahn® vbx devices were patent at the end of the procedure.On (b)(6) 2019, 30 days after implantation, the patient presented with an occlusion of the right renal artery and the viabahn® vbx device, which was placed in the right renal artery, because of thrombosis.The study database indicates that the adverse event was related to this viabahn® vbx device.Hospitalization was required for this event, but no treatment was initiated.It was stated that the patient has complaints since two weeks and the study database indicates that the event is not yet resolved.
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