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 2134265-2015-08552.(b)(4).It was reported that in-stent restenosis and myocardial infarction occurred.In (b)(6) 2015, the patient had not experienced a myocardial infarction in the 72-hour period prior to the index procedure.The qualifying indications included a positive stress test, crescendo angina, intermediate coronary syndrome, and coronary atherosclerosis of a native vessel.There was 1 target lesion and no non-target lesions.The target lesion was a de novo lesion located in the mid-lad with 80% stenosis.It was 28 mm long, with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation with a 2.75 mm balloon catheter at 10 atmospheres and placement of a 3.50 x 28 mm promus¿ premier stent.Post-dilatation was performed with a 3.5 mm catheter at 18 atmospheres.There was 10% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2015, the patient was admitted to the hospital with a 2-day history of increasing lower extremity edema and dyspnea.She complained of progressive fatigue and lightheadedness with normal tasks.She was diagnosed with acute decompensated heart failure secondary to non st segment myocardial infarction (nstemi).The location of the mi was anteroseptal.The patient was treated with 60 mg lasix intravenous (iv) without response and was admitted to cardiology.80 mg lasix iv twice a day, a heparin drip, and bilevel positive airway pressure (bipap) were also administered.Transient atrial fibrillation in the setting of nstemi resolved after 6 hours; there was no prior record of an ecg with atrial fibrillation.Three days post admission, successful intervention of the mid left anterior descending artery (lad) was accomplished with cb ptca (cutting balloon angioplasty).The pre-treatment stenosis of the mid-lad was 95%.The post treatment residual stenosis was 0-10%.Thrombolysis in myocardial infarction (timi) flow was 3 both pre and post procedure.On the same day, successful intervention of the first obtuse marginal artery (om1) branch of the left circumflex artery (lcx) was accomplished with ptca and cb ptca.There were no complications.Two days later, the events nstemi and isr were considered resolved and the patient was discharged on aspirin and plavix (clopidogrel).In (b)(6) 2015, the patient experienced chest discomfort at rest, with the discomfort being similar to that which she had experienced prior to previous percutaneous coronary interventions (pci).She also complained of increased lower limb swelling over the prior few days.An ecg revealed new t-wave inversions in leads 2, 3, avf, v5, and v6.The subject was diagnosed with a nstemi.The following day, the patient underwent successful pci of the culprit lesion, the mid-lad with atherectomy and placement of a 3.50x28 mm non-bsc drug eluting stent.The pre-treatment stenosis was 70-80% and the post treatment stenosis was 0-10%.Thrombolysis in myocardial infarction (timi) flow was 3 both pre and post procedure.Concerning the dissection recorded in the angiography report, this was a very minimal grade a dissection caused by flextome atherectomy, there was no specific intervention targeted for the dissection, as it was very minimal.This dissection did not result in the nstemi on this date.Two days after, the events of nstemi and in-stent restenosis (isr) were considered resolved and the subject was discharged on aspirin and plavix (clopidogrel).
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