Same case as: 2134265-2017-10515 and 2134265-2017-10516.(b)(6) clinical study it was reported that stent restenosis occurred and the patient experienced coronary heart disease.On (b)(6) 2014, the patient presented with an unstable angina (braunwald classification: iia) and was referred for cardiac catheterization.Subsequently, the index procedure was performed.Target lesion #1 was located in the mid left coronary artery (lad) and was treated by placement of a 2.50 x 16 mm promus element ¿ stent.Target lesion #2 was located in the distal left circumflex artery and was treated by placement of a 3.00 x 16 mm promus element ¿ stent.Target lesion #3 was located in the proximal lad and was treated by placement of a 3.50 x 20 mm promus element ¿ stent.On (b)(6) 2014, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2015, 591 days post index procedure, the patient was diagnosed with coronary atherosclerotic heart disease after unstable angina pectoris restenosis and was hospitalized on the same day.On (b)(6) 2015, coronary angiography was performed which revealed the 1st diagonal (target vessel) was 80% stenosed.It was treated with percutaneous coronary intervention (pci) with 0% residual stenosis.The patient then had a blood transfusion.On (b)(6)2015, the event was considered to be recovered/resolved and the patient was discharged on the same day.
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