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