The device will not be returned for evaluation as the stent remains in patient.The reported patient effects of angina and stenosis are listed in the xience sierra, everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent 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.The 3 additional xience sierra stents referenced are being filed under separate medwatch report numbers.
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Patient id: (b)(6).It was reported that on (b)(6) 2019 five xience sierra stents were implanted.One 3.5x38 stent in the first obtuse marginal (om1), one 3.5x18 in the right posterior atrio-ventricular (rpav), and three (2.5x38, two 3.0x38) in the right coronary artery (rca).On (b)(6) 2021 the patient had increasing frequency of angina at rest and had a positive stress test.Coronary angiogram showed stenosis in the om1, rca, and left circumflex coronary artery.There was no stenosis in the rpav.The patient was referred for coronary artery bypass graft surgery.No additional information was provided.
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