Date of event: estimated date.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.It should be noted that the reported patient effects of dyspnea, pain and hypersensitivity are listed in the xience sierra, everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the reported treatment appears to be related to the operational context of the procedure.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 on (b)(6) 2019, the patient presented with weakness, nausea, electrocardiogram changes, and two blockages, one in the proximal left anterior descending (lad) coronary artery, 80% stenosed lesion.That day, a 3.5x23mm xience sierra stent was implanted in the proximal lad without reported issues.Since (b)(6) 2019, the patient stated her stomach and esophagus have been painful, and she has shortness of breath.She suspects an allergic reaction.She is unsure if the reaction is due to the stent or the antiplatelet medications.The patient has been to multiple cardiologists and her antiplatelet medication has been changed three times without any improvement.One physician had placed her on anti-anxiety medications but that has not helped.No additional information was provided regarding this issue.
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