Device is a combination product device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.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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Same case as mdr id# 2134265-2015-05559, 2134265-2015-05560, 2134265-2015-05554, 2134265-2015-05553.(b)(4).In (b)(6) 2010, the patient was referred for cardiac catheterization which revealed the 90% stenosed, de novo target lesion located in the 1st left posterolateral branch segment (lpl) of the left coronary artery that was 12mm long with a reference vessel diameter of 2.25mm.The target lesion was treated with predilatation and placement of a 2.25 x 20mm promus element stent resulting to 0% residual stenosis.One day post index procedure, the patient was discharged on aspirin and prasugrel.In (b)(6) 2014, the patient's cardiac enzymes were found to be elevated and the site reported an event of myocardial infarction (mi).The patient was subsequently hospitalized on the same day.Ecg was performed and the patient was referred for coronary angiography which revealed 50-75% in-stent restenosis in the small postero-lateral branch, in-stent restenosis in the mid segment of the right coronary artery (rca) and 75% stent thrombosis with complete occlusion of the promus element stents in the distal rca which were implanted in june 2010.On the same day, stent thrombosis of the previously implanted promus element stents were treated with thrombus aspiration and implantation of a 2.25 x 11mm non-bsc stent at the origin of the right posterior descending segment of rca, a 2.50 x 24mm stent in the right lpl branch and a 3.50 x 18mm stent in the mid rca.The event was then considered resolved without residual effects.Seven days post procedure, the patient was discharged.
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