It was reported that the patient was unstable in the intensive care units (icu) after the implant procedure with signs of right heart failure, vasoplegia, rising lactate, and low ph.An echocardiogram was performed and the patient returned to the operation room for tamponade (clot evacuation).There was poor improvement after the procedure with hemodynamic compromise and right heart failure.Right sided centrimag support was initiated in the catheterization lab.The device was operating as expected.Despite intervention, the patient showed signs of multi-system organ failure with liver compromise and acute kidney failure.Dialysis was initiated.The decision to stop support was made on (b)(6) 2022 considering lack of improvement and multi-system organ failure, in accordance with patient's and family's wishes.The patient passed away on (b)(6) 2022.
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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 determined through this evaluation.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 28feb2022.The heartmate 3 lvas instructions for use (ifu) and the heartmate 3 lvas patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists multiple types of organ failure and dysfunction, pericardial fluid collection, hemolysis, and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿ (under ¿anticoagulation¿), provides information regarding the recommended anticoagulation regimen, including inr values, as well as suggested anticoagulation modifications in the event that there is a risk of bleeding.No further information was provided.The manufacturer is closing the file on this event.
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