All of the following must be present:

I. Deployment of the device

II. Absence of major device or procedure related serious adverse events, including:

1. Death
2. Stroke
3. Life-threatening bleeding (MVARC scale)
4. Major vascular complications
5. Major cardiac structural complications
6. Stage 2 or 3 acute kidney injury (includes new dialysis)
7. Myocardial infarction or coronary ischemia requiring PCI or CABG
8. Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for 48 h.
9. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention