The customer, a syncardia authorized distributor, reported that the patient passed away on (b)(6) 2021.The customer reported the cause of death as multi-organ system failure and indicated that the tah-t did not cause or contribute to the patient's death.The tah-t was not explanted and no autopsy was performed.Additional information was provided: initial surgery performed (b)(6) 2021.Aortic and mitral valve replacement and repair, surgery performed by a retired (b)(6) surgeon.The surgery failed totally and there was no option to bring back the heart in a viable state.Patient was transferred from heart-lung machine (surgery) directly to ecmo and discharged to icu.The surgery was done in a private clinic around (b)(6).After 10 days of ecmo, a doctor at a certified tah center in (b)(6)) asked if he could advise for a therapeutic option, as a referral.Decision was made to transfer the patient immediately to (b)(6), and plan the tah implant within 48 hours.Implant was done on saturday (b)(6) 2021, despite some initial signs of multi-organ failure.Monday morning mof was confirmed with anuria, liver dysfunction and blood lactates too high.Decision was then made to stop reanimation and be palliative.Patient passed away on monday (b)(6) 2021.
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