(b)(6) clinical study.It was reported that angina and stent thrombosis occurred.In (b)(6) 2013, the patient presented due to stable angina.Subsequently, coronary angiography and index procedure were performed.The target lesion #1 was a de novo lesion located in the proximal left circumflex (lcx) with 90% stenosis and was 15 mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with direct stent placement using a 3.0 mm x 20 mm promus element¿ plus stent, resulting to 0% residual stenosis.The target lesion # 2 was a de novo lesion located in the left main coronary artery (lmca) with 70% stenosis and was 5 mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with direct stent placement using a 3.0 mm x 8 mm promus element¿ plus stent, resulting to 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient presented emergently with complaints of chest discomfort associated with dyspnea and was hospitalized.The coronary angiography revealed 70% in-stent restenosis (isr) of previously deployed 3.0 mm x 20 mm promus element¿ plus stent in the lcx, which was reported as stent thrombosis by site.The 70-90% stenosis extending from proximal lcx to distal lcx was treated with direct stent placement using 2.75 mm x 12 mm, 3.00 mm x 12 mm and 3.0 mm x 23 mm non-bsc drug eluting stents.The event was considered as not resolved at the time of reporting.Two days post procedure, the patient was discharged on aspirin and clopidogrel.
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Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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