Pt undergoing mitral valve transplant due to chronic diastolic congestive heart failure class 3.Surgeon requested 23 mm on-x mechanical mitral valve.Circulating nurse mistakenly selected 23 mm on-x-aortic valve.During verification, circulating nurse and tech followed the mfr's ifu to check the expiration date and serial number against the mfr implant form.The aortic and mitral valves are packaged with an attached holder to prevent manual manipulation and damage to the valve.There is very little visual difference between the aortic valve and holder compared to the mitral valve and holder.Not recognizing he had been given an aortic valve, the surgeon unknowingly implanted an aortic valve instead of the planned mitral valve.Attempts to wean the pt off bypass were unsuccessful and the pt expired in surgery.The implant error was not discovered until the following day.Fda safety report id# (b)(4).
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