Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
15
Table 8 summarizes all serious adverse events observed through 30 days during the
ORBIT II study.
Table 8. Summary of SAEs through 30 Days
SAEs through 30 days
Subjects
N=443
Subjects
n (%)
Events
N
Cardiovascular Disorders 60 (13.5%) 68
Acute MI, Q-wave 4 (0.9%) 4
Acute MI, non Q-wave 39 (8.8%) 39
Angina Pectoris 2 (0.5%) 2
Angina pectoris 2 (0.5%) 2
Atrial fibrillation 2 (0.5%) 2
Atrioventricular block, II degree 1 (0.2%) 1
Cardiac/pericardial tamponade 4 (0.9%) 4
Cardiogenic shock 2 (0.5%) 2
Chest pain 2 (0.5%) 2
Endocarditis 1 (0.2%) 1
Non-target vessel revascularization 1 (0.2%) 1
PEA arrest 1 (0.2%) 1
Pericarditis 1 (0.2%) 1
Shock (Acute RV dysfunction and acute blood loss
hypovolemic)
1 (0.2%) 1
Sick sinus syndrome 1 (0.2%) 1
Ventricular fibrillation 2 (0.5%) 2
Ventricular tachycardia 1 (0.2%) 1
Ventricular tachycardia/ventricular fibrillation 1 (0.2%) 1
Angiographic Complications 7 (1.6%) 7
Coronary artery embolism of air, plaque, thrombosis, or
debris
3 (0.7%) 3
Slow flow or no reflow phenomena 3 (0.7%) 3
Thrombosis formation at site of treated lesion 1 (0.2%) 1
Vascular Disorders 11 (2.5%) 11
Neurologic/Psychiatric Disorders 4 (0.9%) 4
Respiratory/Thoracic Disorders 7 (1.6%) 9
Digestive Disorders 6 (1.4%) 6
Renal/Genitourinary Disorders 2 (0.5%) 2
Death (No disorder specified) 2 (0.5%) 2