The patient was implanted with a left ventricular assist device on (b)(6) 2017.It was reported that the patient's pump flows were elevated.The patient was assessed in the emergency room and everything was negative and numbers returned to normal.Historical data was received, which indicated that in (b)(6) of 2017, a ct angiogram was performed which showed mild reduced diameter of the outflow cannula at the site of ascending aortic anastomosis; area at this level measures 1 cm2 and area proximal to the anastomosis measures 1.8 cm2 (approximately 50% area reduction at the level of anastomosis).The outflow graft cannula was otherwise unremarkable in appearance.The surgical team reviewed the ct angiogram and believed that the narrowing would not limit flow.It was noted that blood pressure has been elevated and may be the cause of the asymptomatic elevated power and flow.No further information was provided.
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A direct correlation between the device and the reported event could not conclusively be established.Review of the submitted system controller log file showed a slight elevation in pump power on 18oct2018 with a corresponding elevation in the estimated pump flow.Pump power and the estimated flow returned to baseline values the following day.No atypical alarms were captured and the pump speed remained above the low speed limit for the duration of the log file.The log file appeared to show the system operating as intended.The instructions for use explains that pump power is a direct measurement of motor voltage and current; therefore, changes in pump speed, flow, or physiological demand can affect pump power.This document also describes how pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.The patient remains ongoing on lvad support with no further related issues reported.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.
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