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.Multiple attempts were made to obtain additional information regarding the reported event; however, no further information was provided by the customer.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C is currently available.Section 1 ¿introduction¿ of this document lists adverse events that may be associated with the use of the heartmate 3 lvas, including death.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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