A4: date of birth should have been redacted for clinical study.Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events could not be conclusively determined through this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 11apr2022.The heartmate 3 lvas instructions for use (ifu) is currently available.This ifu lists neurological dysfunction as an adverse event that may be associated with the use of heartmate 3 lvas.No further information was provided.The manufacturer is closing the file on this event.
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