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.Product event summary: a pump with unknown serial number was not returned for evaluation.This complaint is associated with a clinical adverse event.Log file analysis could not be performed since log files covering the reported event date were not available for analysis.The reported event of "unspecified device malfunction" could not be confirmed due to insufficient evidence.Based on the available information, there is no evidence to indicate that a device malfunction or performance issue caused or contributed to the reported event.Per the hvad instructions for use, arrhythmia is a known potential complication associated with the implantation of an hvad pump.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.This event was reported in the q1 2020 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and 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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