Study: NCT02362646

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 51 affected / 106 at risk

Adverse event: Sustained ventricular dysrhythmia requiring defibrillation or cardioversion
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 106 at risk

Adverse event: Sustained supraventricular dysrhythmia requiring drug treatment or cardioversion
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 106 at risk

Adverse event: Pump thrombus confirmed
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 106 at risk

Adverse event: Pump thrombus suspected
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 106 at risk

Adverse event: Nonpump thrombus related
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 106 at risk

Adverse event: Minor device malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 106 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 106 at risk

Adverse event: Localized nondevice infection
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 106 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 106 at risk

Adverse event: Percutaneous site and/or pocket infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 106 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 106 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 106 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 106 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 106 at risk

Adverse event: Other neurological dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 106 at risk

Adverse event: Renal dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 106 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 106 at risk

Adverse event: Potential Inflammatory Responses
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 106 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 106 at risk

Adverse event: Vasodilatory State
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 106 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 106 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 106 at risk

Adverse event: MI (Non-perioperative)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 106 at risk

Adverse event: Psychiatric Episode
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 106 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 106 at risk

Adverse event: Arterial Non-CNS Thromboembolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 106 at risk

Adverse event: Venous Thromboembolism Event
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 106 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 106 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 106 at risk

Adverse event: Sustained SVT dysrhytmia
Serious: yes
Organ System: Cardiac disorders
Notes: Sustained supraventricular dysrhythmia requiring drug treatment or cardioversion
Frequency: 14 affected / 106 at risk

Adverse event: Localized nondevice infection
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 106 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 106 at risk

Adverse event: Sustained supraventricular dysrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Sustained supraventricular dysrhythmia requiring drug treatment or cardioversion
Frequency: 14 affected / 106 at risk

Adverse event: Localized nondevice infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 106 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 106 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 28 affected / 53 at risk

Adverse event: Sustained ventricular dysrhythmia requiring defibrillation or cardioversion
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 53 at risk

Adverse event: Sustained supraventricular dysrhythmia requiring drug treatment or cardioversion
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 53 at risk

Adverse event: Pump thrombus confirmed
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 53 at risk

Adverse event: Pump thrombus suspected
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 53 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 53 at risk

Adverse event: Localized nondevice infection
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 53 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 53 at risk

Adverse event: Percutaneous site and/or pocket infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 53 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 53 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Other neurological dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 53 at risk

Adverse event: Renal dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 53 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 53 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 53 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 53 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 53 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 53 at risk

Adverse event: Venous Thromboembolism Event
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 53 at risk

Adverse event: Sustained SVT dysrhytmia
Serious: yes
Organ System: Cardiac disorders
Notes: Sustained supraventricular dysrhythmia requiring drug treatment or cardioversion
Frequency: 3 affected / 53 at risk

Adverse event: Localized nondevice infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 53 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk

Adverse event: Sustained supraventricular dysrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Sustained supraventricular dysrhythmia requiring drug treatment or cardioversion
Frequency: 3 affected / 53 at risk

Adverse event: Localized nondevice infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 53 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 53 at risk