(b)(4).The device was not returned for evaluation.A review of the electronic lot history record (elhr) revealed no non-conformities associated with this lot.The reported patient effects of cardio-respiratory arrest (respiratory distress) and heart failure (cardiac failure) 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.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a moderately calcified left circumflex artery that was 90% stenosed.On (b)(6) 2018, the patient presented with ischemia without any symptoms.Therefore, a 2.5 x 28 mm xience sierra stent was implanted in the lesion.It was confirmed that the patient was compliant with dual antiplatelet drug therapy after the procedure.Then on (b)(6) 2018, the patient was urgently re-hospitalized for respiratory distress and heart failure.Therefore, furosemide, nicardipine and potassium aspartate were administered intravenously.Additionally, oxygen therapy (bilevel positive airway pressure (bipap)) was performed.On (b)(6) 2018, spironolactone and furosemide were administered orally.On (b)(6) 2018, intravenous injection of potassium aspartate was stopped.On (b)(6) 2018, oxygen therapy was stopped.On (b)(6) 2018, the patient recovered and was discharged from the hospital.It remains unknown whether the stent is patent or not.It was reported that the device did not cause or contribute to the adverse patient effects.There was no adverse patient sequela reported.No additional information was provided.
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