This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Event summary: a pump with unknown serial number was not returned for evaluation.Log file analysis could not be performed since log files covering the reported event date were not available for analysis.The reported event could not be confirmed due to insufficient evidence.Based on the limited information available, there is no evidence to suggest that a device malfunction caused or contributed to the reported event.This event was reported in the 2019 euromacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain patient or device identifying information therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.If information is provided in the future, a supplemental report will be issued.
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