Study: NCT02170363

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 50 at risk

Adverse event: Bleeding - Requiring Surgery
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 50 at risk

Adverse event: Bleeding - Gastrointestinal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 50 at risk

Adverse event: Cardiac Arrhythmias - Ventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 50 at risk

Adverse event: Pericardial Fluid
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Internal Device Malfunction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 50 at risk

Adverse event: External Device Malfunctions
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 50 at risk

Adverse event: Any Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 50 at risk

Adverse event: Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 50 at risk

Adverse event: Infection - Driveline
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Any Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 50 at risk

Adverse event: Stroke - Ischemic
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 50 at risk

Adverse event: Stroke - Hemorrhagic
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Neurologic Dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Psychiatric Episode
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 50 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 50 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 50 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 50 at risk

Adverse event: Right Heart Failure - requiring RVAD
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 50 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Other Serious Adverse Event
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 50 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 50 at risk

Adverse event: Cardiac Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 50 at risk

Adverse event: Cardiac Arrhythmias - Supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 50 at risk

Adverse event: External Device Malfunction
Serious: no
Organ System: Product Issues
Frequency: 11 affected / 50 at risk

Adverse event: Any infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 50 at risk

Adverse event: Neurologic Dysfunction
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Other Non-serious Adverse Event
Serious: no
Organ System: General disorders
Frequency: 10 affected / 50 at risk