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: the sewing ring with unknown lot number, along with its accessories, was not returned for evaluation.The reported event could not be confirmed since the components were not returned and no evidence or supporting data was provided.There is no evidence to suggest that a component malfunction caused or contributed to the reported event.Based on historical review of similar events, the most likely root cause of the reported damage can be attributed to excessive stress applied by tightening the screw at an angle due to limited access to the implant site or the screw was not fully supported by the sewing ring clamp, which could be caused by the user backing the screw out of the intended position, resulting in the screw breaking under load.If information is provided in the future, a supplemental report will be issued.
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