There was no reported device malfunction and the product was not returned.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, occlusion and stenosis are listed in the instruction for use everolimus eluting coronary stent systems xience xpedition, as known patient effect 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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Patient id: (b)(6).It was reported that on (b)(6) 2014, the patient presented with chest pain.Coronary angiography was performed, showing 85% stenosis in the proximal right coronary artery (rca) and a 3.5x38mm xience xpedition stent was successfully implanted.On (b)(6) 2014, the patient was discharged.On (b)(6) 2018, the patient was re-hospitalized for chest tightness.On (b)(6) 2018, coronary angiography showed 100% occlusion in the stent in the proximal rca.Balloon dilatation was performed.On (b)(6) 2018, the patient was discharged.On (b)(6) 2019, the patient was re-hospitalized for shortness of breath, chest tightness and neck tightness.On (b)(6) 2019, coronary angiography noted 100% restenosis.Two non-abbott stents were implanted.On (b)(6) 2019, the patient was discharged, but was still experiencing some symptoms.No additional information was provided.
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