Table 3.

Key safety events adjudicated by an independent medical monitor

Event	% (n/N)	Device-related, n
All-cause mortality at 30 days	0.9% (4/443)	1
Serious adverse events (% of subjects) at 30 days	8.6% (43/499)	1
Additional key safety events at 30 days*
Rethrombosis/residual thrombus	4.8% (24/499)	0
Pulmonary embolism	0.8% (4/499)	1
Acute kidney injury	0% (0/499)	0
Valve or vessel damage	0% (0/499)	0
Rethrombosis/residual thrombus at 6 months	8.0% (40/499)	0

^*SAE terms follow Medical Dictionary for Regulatory Activities (MedDRA) terminology