The device was not returned for evaluation.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 system (eecss), electronic 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.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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It was reported that a 2.5x15mm xience sierra stent was implanted on (b)(6) 2020.The patient presented with congestive and hypotensive heart failure before the procedure.On (b)(6) 2020, 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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