(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.It should be noted that the xience sierra, everolimus eluting coronary stent system, instructions for use (eifu) states: note the product use by (expiration) date specified on the package (product label).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 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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It was reported that the procedure was to treat a de novo, chronic total occlusion of the 1st obtuse marginal coronary artery.The 2.25x23 mm xience sierra stent was advanced and successfully implanted.However, after the procedure, it was noted that the expiration date of the device was 05/09/2019.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
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