(b)(4).Evaluation summary: the device was returned for analysis.The failure to advance could not be replicated in a testing environment as it was based on operational circumstances.Additionally, a torn shaft was confirmed.Based on a visual and dimensional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query/review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the reviewed information, no product deficiency was identified.The xience pro is currently not commercially available in the us.
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