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 effects of angina, stenosis, dizziness and dyspnea are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, 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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Patient id: (b)(6).It was reported that on (b)(6) 2018, a 3.5 x 18 mm xience sierra stent was implanted to treat a lesion in the proximal circumflex artery.The patient was discharged to home the day of the procedure.On (b)(6) 2020, the patient had complaints of dyspnea on exertion, dizziness and non-radiating left sided chest pain, occurring during exertion and resolving with rest.Coronary angiogram was performed in-stent restenosis was noted in the circumflex (cx) artery.An additional drug eluting stent was implanted as treatment.No additional information was provided.
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