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 hypertension is listed in the xience sierra, everolimus eluting coronary stent systems instructions for use ifu) as a 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.
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It was reported that on (b)(6) 2020, the patient, with a history of non-st elevation myocardial infarction, underwent a coronary stenting procedure, with implantation of a 2.75 x 15 mm xience sierra stent.On (b)(6) 2020, the patient was re-admitted with hypotension and heart failure.Medication was administered as treatment.No additional information was provided.
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