(b)(4).Exemption number e2019001.The device was not returned for analysis.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use, states: note the product use by (expiration) date specified on the package.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported device expiration issue appears to be related to the use error.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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