Device is a combination product.Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
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Promus element (b)(6) clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2014, the patient presented due to unstable angina and was referred for cardiac catheterization.Subsequently, the index procedure was performed.The target lesion was located in the proximal left anterior descending (lad) artery with 70% stenosis and was 24mm long with a reference vessel diameter of 3.0mm.The target lesion was treated with direct placement of a 3.00x28mm promus element ¿ drug-eluting stent.Following post-dilatation, residual stenosis was 0%.After four days, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2018, the patient was noted with in-stent restenosis and hospitalized on the same day.After eight days, the 80% stenosis noted in the left main coronary artery (lmca) extending up to proximal lad which had previously placed study stent was treated with stent implantation.Post intervention, the residual stenosis was 0%.Three days after, the event was considered to be recovered/resolved and the patient was discharged on the same day.
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