Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported event of respiratory failure, as well as the subsequent patient outcome could not be conclusively determined through this evaluation.The account indicated that the death was not considered to be device-related, and that the device operated as expected.No autopsy was performed, the device was not explanted for evaluation.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 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1, ¿introduction¿, lists respiratory failure and death as adverse events that may be associated with the use of heartmate 3 lvas.No further information was provided.The manufacturer's investigation is complete.
|