Study: NCT01966458

Adverse event: Major Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 156 affected / 308 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 95 affected / 308 at risk

Adverse event: Device Malfunction/Failure
Serious: yes
Organ System: Product Issues
Frequency: 60 affected / 308 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 308 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 308 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 308 at risk

Adverse event: Major Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 150 affected / 308 at risk

Adverse event: Neurological Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 57 affected / 308 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 308 at risk

Adverse event: Psychiatric Episode
Serious: yes
Organ System: Psychiatric disorders
Frequency: 34 affected / 308 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 32 affected / 308 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 61 affected / 308 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 94 affected / 308 at risk

Adverse event: Arterial Non-CNS Thromboembolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 308 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 308 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 308 at risk

Adverse event: Other Intermacs
Serious: yes
Organ System: General disorders
Frequency: 219 affected / 308 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 308 at risk

Adverse event: Device Malfunction/Failure
Serious: no
Organ System: Product Issues
Frequency: 18 affected / 308 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 308 at risk

Adverse event: Major Infection
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 308 at risk

Adverse event: Other Intermacs
Serious: no
Organ System: General disorders
Frequency: 29 affected / 308 at risk

Adverse event: Major Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 87 affected / 157 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 42 affected / 157 at risk

Adverse event: Device Malfunction/Failure
Serious: yes
Organ System: Product Issues
Frequency: 38 affected / 157 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 157 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 157 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 157 at risk

Adverse event: Major Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 85 affected / 157 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 157 at risk

Adverse event: Neurological Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 24 affected / 157 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 157 at risk

Adverse event: Psychiatric Episode
Serious: yes
Organ System: Psychiatric disorders
Frequency: 11 affected / 157 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 23 affected / 157 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 157 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 56 affected / 157 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 157 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Other Intermacs
Serious: yes
Organ System: General disorders
Frequency: 106 affected / 157 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 157 at risk

Adverse event: Device Malfunction/Failure
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 157 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 157 at risk

Adverse event: Major Infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 157 at risk

Adverse event: Other Intermacs
Serious: no
Organ System: General disorders
Frequency: 8 affected / 157 at risk