It was reported that the patient was admitted with a complaint of chest pain and shortness of breath.The patient¿s lactate dehydrogenase (ldh) level was 503 on (b)(6) 2024.Initially, the chest pain and shortness of breath was attributed to a suspected pump clot.A ramp echocardiogram (echo) was ordered to rule out thrombosis.It was reported that the patient would remain inpatient at the time.It was later reported that the ramp study results were inconclusive; a right heart catheterization was then performed showing normal filling pressures, leading to low suspicion for pump thrombus.Ultimately, pump thrombus could not be confirmed, and the cause of the reported events is unknown.The patient would continue to be monitored and remain on anticoagulation per protocol.
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Manufacturer's investigation conclusion: the suspected device thrombosis could not be confirmed through this evaluation.A direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively established through this evaluation.Additionally, a direct correlation between the reported events and the suspected thrombus could not be conclusively established.The submitted log files collectively contained data and events from 24jan2024 ¿ 31jan2024 and 01feb2024 ¿ 07feb2024.No notable events or alarms were captured.The pump appeared to function as intended at the fixed speed throughout the duration of the file.The patient remains ongoing on heartmate ii lvas, serial number (b)(6), and no further related events have been reported 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 specifications.The heartmate ii lvas instructions for use (ifu), rev.C, is currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including device thrombosis and hemolysis, that may be associated with the use of the heartmate ii lvas.The patient care and management section of the ifu outlines the indications of thrombus and how to respond to such events.This document also provides the recommended anticoagulation regimen, as well as suggested anticoagulation modifications.No further information was provided.The manufacturer is closing the file on this event.
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