On (b)(6) 2015, the surgeon reported to the sales rep that there were two patients who experienced strokes after being treated with the fusion 150 and an unspecified atriclip product.Originally, the ep, suggested that the strokes are originating from manipulation of the laa during clip placement.However, after several conversations with the surgeon who performed the procedures with the surgeon who performed the procedures, he believes that the strokes were a result of surgical compilations with the use of the fusion 150 device.The first case, submitted on this medwatch, occurred (b)(6) 2013.The patient experienced a stroke 36 hours post-surgery.Neurosurgery intervention was performed but there was no recovery.The patient expired 48 hours post neurosurgery.The second event reported occurred (b)(6) 2015, and will be submitted on a separate medwatch report# 003502395-2015-00021.
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