1.2
Instructions for Use & Clinical Reference Manual (US)
POTENTIAL ADVERSE EVENTS (UNITED STATES)
Below is a list of the potential adverse effects (e.g., complications) associated with the use of the
Impella RP system:
• Arrhythmia
• Atrial fibrillation
• Bleeding
• Cardiac tamponade
• Cardiogenic shock
• Death
• Device Malfunction
• Hemolysis
• Hepatic failure
• Insertion site infection
• Perforation
•
Phlegmasia cerulea dolens (a severe form of deep venous thrombosis)
• Pulmonary valve insufficiency
• Respiratory dysfunction
• Sepsis
• Thrombocytopenia
• Thrombotic vascular (non-central nervous system) complication
• Tricuspid valve injury
• Vascular injury
• Venous thrombosis
• Ventricular fibrillation and/or tachycardia
