Specifications

Diamondback360®CoronaryOrbitalAtherectomySystem

10



7. Adverse events

Potential adverse events that may occur and/or require intervention include, but are not

limited to:

 Allergic reaction to medication/media/device components

 Aneurysm

 Angina (ischemic chest pain)

 Arrhythmias

 Arteriovenous fistula

 Bleeding

 Bruising/hematoma

 Cardiac/cardiopulmonary arrest

 Cardiac/pericardial tamponade

 Cerebrovascular accident (CVA)

 Death

 Embolization, distal (air, tissue, thrombus, device)

 Emergent coronary artery bypass graft surgery (CABG)

 Failure to deliver the system to the intended locations

 Fever

 Heart failure/dysfunction

 Hemorrhage, requiring transfusion

 Hypotension/hypertension

 Infection

 Myocardial infarction

 Pain

 Pericardial effusion

 Pseudoaneurysm

 Restenosis of treated segment leading to revascularization

 Renal insufficiency/failure

 Shock (cardiogenic, hypovolemic)

 Slow flow or no reflow phenomenon

 Stroke

 Thrombus

 Vessel closure, abrupt

 Vessel injury, requiring surgical repair

 Vessel dissection, perforation, rupture, or spasm

 Vessel occlusion