Device is a combination product.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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(b)(4) clinical study.It was reported that chest pain and in-stent restenosis occurred.In (b)(6) 2013, the patient was noted to have silent ischemia, abnormal stress test or imaging stress test indicative of ischemia.Subsequently, coronary angiography and index procedure were performed.The target lesion was located in the mid left anterior descending (lad) artery with 65% stenosis and was 10mm long with a reference vessel diameter of 2.5mm.The lesion was treated with pre-dilatation and placement of a 2.50x12mm study stent with 0% residual stenosis.On the following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient presented with the 5 days history of chest pain and dizziness.Subsequently, the patient was hospitalized on the same day for further evaluation.On the following day, coronary angiography was performed and revealed 85% ostial stenosis; 25% in-stent restenosis (isr) in proximal stent; isr of study stent in mid-lad.On the same day, 85% stenosis in the ostial proximal lad was treated with pre-dilatation and placement of 3.0mmx8mm promus premier stent with 0% residual stenosis.On the following day, the patient was discharged on dual antiplatelet therapy in stable condition.
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