(b)(4) clinical study.It was reported that myocardial infarction (mi), in-stent thrombosis and cardiac arrest occurred.In (b)(6) 2013, clinical status assessment identified that the patient's qualifying condition as stable angina.Prior to the procedure, the subject underwent abnormal stress test or imaging test indicating ischemia and other objective evidence of ischemia.Subsequently, index procedure was performed.The target lesion was located in the mid left anterior descending (lad) with 80% stenosis and was 8 mm long with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 12 mm study stent.Following post-dilatation residual stenosis was 0%.The following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2016, the patient presented to non-study hospital with complaints of sudden onset of severe midsternal chest discomfort while trying to move a refrigerator and the patient was hospitalized on the same day.During his stay in er, the patient underwent electrocardiogram (ecg) on the same day which revealed sinus rhythm with anterior st elevation consistent with acute mi.The patient also underwent telemetry which revealed sinus rhythm.Subsequently, the patient was transferred to study hospital for cardiac catheterization.Upon examination, the patient was noted to be in severe distress secondary to chest pain.Of note, site has stated that "pi reviewed angiogram films and protocol definition to confirm that event was a very late stent thrombosis as timi flow of 0 with occlusion originating in the segment 5mm proximal to stent in the presence of thrombus along with new onset ischemic symptoms at rest and new ischemic ecg changes".Cardiac catheterization revealed 100% stenosis located in the mid lad extending to proximal lad of the previously placed study stent which was treated with pre-dilatation resulting in timi flow 2.Eventually thrombus was noted throughout the study stent.During the procedure, post pre-dilatation, the patient was noted to have ventricular fibrillation cardiac arrest which required external defibrillation as well as advanced cardiac life support (acls).The patient became hypotensive and treated with dopamine drip.Cardiac procedure was put on hold due to patient's unstable nature and was given zofran as a response to it.The patient was then stented with 3.25x33 non-bsc drug eluting stent.Immediately post stent deployment, repeat angiography revealed timi flow 3, patent proximal lad stent and 0% residual stenosis.The patient was elected for a balloon pump as the patient remained hypotensive requiring pressor therapy with large anterior mi.The patient was then transferred to cardiac intensive care unit and had developed pulmonary edema and mild congestive heart failure.During the patient¿s stay in hospital, he complained of abdominal discomfort and was ordered for ct of abdomen, which revealed no acute abnormality.It was felt that most of patient¿s discomfort was related to excessive gas.Five days after, the patient was discharged on home medications and was advised to follow up with his primary care physician to ensure that patient's renal function was stable.
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