(b)(4).Exemption number e2019001.The device was not returned for analysis.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.It should be noted that the xience alpine everolimus eluting coronary stent system instructions for use states: do not use after the use by date.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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