The patient was implanted with a left ventricular assist device (lvad).It was reported that on (b)(6) 2017, the clinician observed elevated pump power and estimated flow readings in the system controller history file.The system controller log files were submitted and reviewed by the manufacturer¿s technical services representative, and pump stoppage events were observed.It was reported that the patient remained asymptomatic during the events.The patient was admitted with a lactate dehydrogenase (ldh) level elevated of 1062 u/l.The patient was treated with angiomax and primacor infusions.On (b)(6) 2017, the patient¿s pump was turned off due to multiple pump stoppage events.The patient was also listed 1a status for a heart transplant.As of (b)(6) 2017, the patient remained on the transplant list with device support turned off.
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No product was returned for evaluation.A direct correlation between the device and the reported event could not conclusively be established.A review of the submitted log files confirmed a significant increase in pump power over time, as well as elevated flow values and nearly constant pi events.Additionally, pump stoppages were captured on (b)(6) 2017 at 12:11 while the patient was supported by battery power, and at 21:49 while the patient was supported by the power module.Although the pump ramped back up to its set speed following these events, power remained elevated over 20 watts and continued to trend upward.Based on past experience with the heartmate ii lvas and similar reported events, this data could be indicative of potential device thrombosis; however, a specific cause for these events could not conclusively be determined through this evaluation.Thrombus and hemolysis are listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system.A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.
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