As reported in a research article, out of 24 patients implanted with an aortic valve, 20 of which had a regent valve implanted, one patient had need a pacemaker due to heart block, and two others had a re-sternotomy due to bleeding.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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It was reported in an article titled, "chimney bentall procedure in the small aortic root after prior aortic valve operations" that regent valves with sizes of 21 mm or smaller were implanted in 20 of 24 patients with a small aortic annulus in 3 hospitals in (b)(6.One patient underwent pacemaker implantation for a heart block after the procedure, and two others had a re-sternotomy due to bleeding.The patients underwent the procedure with a self-assembled valvular conduit using a vascular graft and any valve prosthesis.Additional information could not be obtained.
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