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 and stenosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary 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.The 2.75 x 18 mm xience sierra stent referenced is filed under a separate medwatch report number.
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It was reported that the procedure was performed on (b)(6) 2020, to treat target lesions in the mid and proximal left anterior descending (lad) artery and the proximal circumflex (cx)artery.Two stents were implanted in the lad (3.0 x 28 mm xience sierra stent mid lad, 3.5 x 12 mm xience sierra stent proximal lad).A 2.75 x 18 mm xience sierra stent was implanted in the proximal cx artery.On (b)(6) 2020, the patient was re-hospitalized with recurrent angina.Restenosis was noted in the 3.0 x 28 mm xience sierra stent implanted in the mid lad and in the 2.75 x 18 mm xience sierra stent implanted in the proximal cx artery.Revascularization was performed, with angioplasty performed at both sites.A non-abbott stent was implanted to treat the mid lad; however, no additional stenting was performed in the cx.The adverse patient effect resolved on (b)(6) 2020.No additional information was provided.
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