Exemption number (b)(4).There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of hypertension is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.Additionally, treatment and hospitalization appear to be related to circumstances of the procedure.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 a 3.5x18mm xience sierra stent was implanted on (b)(6) 2019.The patient presented with hypertensive heart before the procedure.On (b)(6) 2019, the patient was re-admitted with hypertensive heart.Unspecified treatment was performed, and the final patient outcome is unknown.No additional information was provided.
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