On (b)(6) 2019 a patient received an avr, plus 1 graft, after presenting to the hospital with cardiac arrest with low ejection fration (ef) and atrial fibrillation (af).The manufacturer was notified of the following.A perceval s sutureless aortic heart was implanted, all visual checks were completed, no pinwheeling or over-sizing noted.Patient was taken off pump and the site noticed a paravalvular leak.After reopening they noticed the cage was higher and had slightly migrated.The valve was explanted and recollapsed.The site re-positioned the perceval in the annulus.On visual inspection the cage did look lower after second implant.The patient came off pump successfully.It was reported that the following day the patient had a cardiac arrest.They re-operated to inspect, but the patient suffered cardiac arrest and passed away.It was deemed not valve related and most likely due to air.
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