It was reported that the patient had an elevated lactate dehydrogenase (ldh).The log files showed multiple elevated powers/flows on (b)(6) 2022.The patient's ldh quadrupled after being placed on intravenous heparin.The ldh was greater than 1000 and haptoglobin was undetectable.The left ventricular assist device (lvad) was unable to be decreased from 11,000 rotations per minute.A computed tomography was performed.The patient was clinically stable.As of (b)(6) 2022, the patient was on day 11 of a thrombosis work up.There was not much change on device interrogation and remained stable.A further log file noted two unsustained power/flow elevations on (b)(6) 2022.On (b)(6) 2022 the patient presented to the emergency room with hypoxia, garbled speech, confusion, and cool extremities with heart rate in 70's and mean arterial pressure in 80's.The log file downloaded that day showed no unusual events.
|
Manufacturer's investigation conclusion: the reported event of the pump being unable to decompress the left ventricle could not be confirmed as no images were submitted for analysis and the device was not returned.A direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the reported events of suspected thrombus, elevated lactate dehydrogenase (ldh), neurologic dysfunction, and failure to thrive could not be conclusively established through this evaluation.The submitted log files contained data from (b)(6) 2022 through (b)(6) 2022 and (b)(6) 2022 through (b)(6) 2022.Transient elevations in pump power and estimated flow slightly above the patient¿s baseline were recorded with at least one elevation captured during a pulsatility index event.No other notable events or alarms were captured.The pump appeared to operate as intended at or above the low speed limit for the duration of the files.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specification.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu), is currently available.Section 1, ¿introduction¿, lists the adverse events that may be associated with the use of the heartmate ii lvas, including device thrombosis, hemolysis, neurologic dysfunction, and death.This section also addresses all pump parameters including pump speed, power, flow, and pulsatility index (pi).In reference to power, this section 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 section also notes that any increase in power not related to increased flow causes erroneously high flow readings.Section 6, ¿patient care and management¿ (under ¿pump performance monitoring¿), explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.This section also provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.Additionally, this section lists neurologic dysfunction as a potential late postimplant complication.No further information was provided.The manufacturer is closing the file on this event.
|