Manufacturer's investigation conclusion: the relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1, "introduction," lists sepsis and death as adverse events which may be associated with the use of heartmate 3 lvas.A direct correlation between the device and the reported events, as well as patient outcome, could not be conclusively established through this evaluation.No further information was provided.The manufacturer is closing the file on this event.
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