Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively established through this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6), with no further related issues at this time.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), rev.A, is currently available.Section 1 of the ifu entitled ¿introduction¿, lists adverse events that may be associated with the use of the heartmate 3 lvas, including pericardial fluid collection.No further information was provided.The manufacturer is closing the file on this event.
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