On (b)(6) 2011, medtronic corevalve received information.That 22 hours following the implant of this bioprosthetic valve.The patient died, due to perforation of the right ventricle by the st.Jude pacel 6f temporary pacing lead (not balloon tipped), causing a pericardia effusion and tamponade.It is also reported, that the patient possibly had a myocardial infarction.This was not confirmed.There were no other complications with the implant of the valve.A proctor was present at implant.The valve was situated high in the aorta.Post implant, there was grade i aortic insufficiency.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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