 - No device or procedure related Serious Adverse Events SAEs Life threatening bleed; major vascular or cardiac structural complications requiring unplanned reintervention or surgery; stage 2 or 3 Acute Kidney Injury includes new dialysis; Myocardial Infarction MI or need for percutaneous coronary intervention PCIcoronary artery bypass graft CABG; severe heart failure HF or hypotension requiring intravenous IV inotrope, ultrafiltration or mechanical circulatory support; prolonged intubation 48 hours 