Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(4), and the patient¿s outcome could not be conclusively established through this evaluation.Due to patient privacy laws, the account declined to communicate additional information regarding the event.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.G, is currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events that may be associated with the use of the heartmate 3 lvas, including death.No further information was provided.The manufacturer is closing the file on this event.
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