It was reported that the patient was admitted from clinic with orthostatic lightheadedness and left ventricular assist device (lvad) speed drops (down to 5400 rpm).The patient's speed was dropped to 5800 from 5900 to help with pulsatility index (pi) events and dropping to low speed limit.It was also reported that the patient underwent an echo the next day.The results showed the interventricular septum (ivs) midline, the aortic valve not open, mildly reduced right ventricular systolic function (rvsf), and left ventricular end diastolic diameter (lvedd) of 4.15.On admission, isosorbide 20 mg ter in die (tid) was discontinued to improve preload and doxazosin changed from 8 mg quaque hora somni (qhs) to 4 mg bis in die (bid).The patient was continued with home diuretic regimen of 1 mg bumex pro re nata (prn) with daily weight checks (discharge weight 97.1 kg).The patient stated that they could feel the pump slow down and speed back up as well as endorsing lightheadedness.
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Manufacturer's investigation conclusion: a direct correlation between the device and the reported events could not be conclusively established through this evaluation.The submitted log files captured several pi events with the pump's speed decreasing to the low speed limit of 5500 rpm.The pump appeared to have operated as intended at the set speed.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) is currently available.Section 1, ¿introduction,¿ lists right heart failure as an adverse event which may be associated with the use of heartmate 3 lvas.This section also provides explanations regarding pump parameter, including pump speed, and states that the device¿s rotor speed will periodically depart from the set speed value (2000 rpm above and 2000 rpm below the set speed) to contribute a flow disruption that in some ways mimics native cardiac contractility.Section 2.¿system operations,¿ provides indication of when the pump is operating in pulse mode and explains that while in this mode, the heartmate 3 pump will automatically modify its speed to create an artificial pulse once every 2 seconds.Section 5, "surgical procedures," warns that moderate to severe aortic insufficiency must be corrected at the time of device implant.If not addressed, the lvas will not be able to provide the intended flow.No further information was provided.The manufacturer is closing the file on this event.
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