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 occlusion 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.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.
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Patient id: (b)(6).It was reported that on (b)(6) 2020 the 2.5x28 mm xience sierra stent was implanted in the distal right coronary artery.On (b)(6) 2020 the patient had angina and was seen in the emergency room.A coronary angiogram on (b)(6) 2020 showed the study stent was patent, but there was a 90% occlusion in the right posterior descending artery, which was within 5 mm of the study stent.A stent was implanted to treat the occlusion and the condition resolved.No additional information was provided.
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