Manufacturer's investigation conclusion: a specific cause for the reported right ventricle dysfunction, hemorrhagic stroke, and subsequent patient outcome, as well as a direct correlation to heartmate 3 left ventricular assist system (lvas), serial number (b)(4), could not be conclusively determined through this evaluation.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 14oct2020.The current heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) lists right heart failure, stroke, and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system in section 1, ¿introduction¿.Neurological dysfunction is also listed as a potential late postimplant complication in section 6 ¿patient care and management¿.Section 6 entitled ¿patient care and management¿ cautions the user that right heart failure can occur following implantation of the pump and warns that ¿right heart dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump¿.This section also outlines the associated treatment options, including rvad placement.Section 6 (under "anticoagulation") also outlines the recommended anticoagulation regimen (including inr range) for patients using the heartmate 3 lvas as well as the suggested anticoagulation modifications in the event there is a risk of bleeding.No further information was provided.The manufacturer is closing the file on this event.
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