The device was not returned for evaluation as the stent remains implanted.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 stenosis and angina are listed in the xience sierra everolimus eluting coronary stent systems 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.However, the 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.
|
Patient id: (b)(6).It was reported that on (b)(6) 2019 two xience sierra stents, sizes 3.0x18 and 3.5x28 were implanted in the mid right coronary artery (rca).On (b)(6) 2021 the patient reported anginal symptoms during an office visit.A left heart catheterization was performed on (b)(6) 2021 although the patient no longer had chest pain or shortness of breath.A stent was placed in the rca.The troponin levels were negative.The patient was discharged the same day, (b)(6) 2021.No additional information was provided.
|