(b)(6) study.It was reported that valve thrombosis, congestive heart failure (chf), myocardial infarction (mi) and death occurred.The patient was enrolled into the (b)(6) study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was on a prior regimen of aspirin and other antiplatelet medications.A lotus introducer was placed and the aortic valve was treated with balloon valvuloplasty (bav).No conduction disturbances developed post bav.The aortic valve was treated with deployment of a 27 mm lotus edge valve.Successful repositioning of the 27mm lotus edge valve involved complete and partial re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).Seven days post index procedure, the patient was discharged on aspirin and clopidogrel.160 days post index procedure, echocardiogram and lab tests revealed prosthetic aortic valve stenosis/ thrombus and chf.Cardiac enzyme (troponin) was elevated consistent with protocol definition of mi.Echo revealed increased gradient suggesting bio-prosthetic obstruction.Aortic valve mean gradient was 34 mmhg, av pk grad 56 mmhg, av vmax 3.74 m/s suggesting thrombosis of valve.The events were treated medically and resulted in prolongation of hospitalization.Angiogram and angiography without revascularization were performed.The following day, 161 days post index procedure, the patient died.
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Reprise iv study: it was reported that valve thrombosis, congestive heart failure (chf), myocardial infarction (mi) and death occurred.The patient was enrolled into the reprise iv study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was on a prior regimen of aspirin and other antiplatelet medications.A lotus introducer was placed and the aortic valve was treated with balloon valvuloplasty (bav).No conduction disturbances developed post bav.The aortic valve was treated with deployment of a 27 mm lotus edge valve.Successful repositioning of the 27mm lotus edge valve involved complete and partial re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).Seven days post index procedure, the patient was discharged on aspirin and clopidogrel.160 days post index procedure, echocardiogram and lab tests revealed prosthetic aortic valve stenosis/ thrombus and chf.Cardiac enzyme (troponin) was elevated consistent with protocol definition of mi.Echo revealed increased gradient suggesting bio-prosthetic obstruction.Aortic valve mean gradient was 34 mmhg, av pk grad 56 mmhg, av vmax 3.74 m/s suggesting thrombosis of valve.The events were treated medically and resulted in prolongation of hospitalization.Angiogram and angiography without revascularization were performed.The following day, 161 days post index procedure, the patient died.It was further reported that in august 2020, 160 days post index procedure, the patient presented emergently with complaints of sharp chest pain which radiated to the left arm and lower led edema persistent for two days.Upon admission, physical examination revealed jugular vein distention and lower leg edema.Heart rate and rhythm and breathing sounds were normal.On the same day, echocardiogram revealed high mean aortic gradient and low left ventricular ejection fraction which per source was due to prosthetic aortic valve stenosis/ thrombus.Chest x-ray revealed cardiomegaly with mild pulmonary edema.Further lab tests indicated elevated probnp value=558.The subject was diagnosed with congestive heart failure (chf).The following day, the subject's condition was noted to be have worsened with worsening chest pain and hypotension; subject was urgently taken to the cath lab.In the cath lab, the subject's grafts were noted to be patent, but the aortic valve was noted to be severely stenosed.The subject however went into a cardiac arrest.Code blue was called, and return of spontaneous circulation (rosc) was achieved quickly and the patient started talking soon afterwards; intubation removed.However, shortly the subject experienced a second pulseless electrical activity (pea) arrest, and was intubated again.However, resuscitation attempts failed.The primary cause of death was cardiopulmonary arrest.
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