Study: NCT01760291

Adverse event: Anemia Requiring Transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 576 at risk

Adverse event: Anemia Requiring Transfusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 576 at risk

Adverse event: Anemia Requiring Transfusion
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 576 at risk

Adverse event: Anemia Requiring Transfusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 576 at risk

Adverse event: Bleeding from Varicose Veins
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 576 at risk

Adverse event: Bleeding, Other
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 576 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 576 at risk

Adverse event: Cranial Bleed
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 576 at risk

Adverse event: Cranial Bleed
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 576 at risk

Adverse event: Death - Non-Cardiovascular
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 576 at risk

Adverse event: Death - Non-Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 576 at risk

Adverse event: Death - Non-Cardiovascular
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 576 at risk

Adverse event: Death - Non-Cardiovascular
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 576 at risk

Adverse event: Death - Non-Cardiovascular
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 576 at risk

Adverse event: Death - Non-Cardiovascular
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 576 at risk

Adverse event: Death - Non-Cardiovascular
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 576 at risk

Adverse event: Death - Non-Cardiovascular
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 576 at risk

Adverse event: Death - Non-Cardiovascular
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 576 at risk

Adverse event: Death - Non-Cardiovascular
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 576 at risk

Adverse event: Death - Non-Cardiovascular
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 576 at risk

Adverse event: Death- Cardiovascular/Unexplained
Serious: yes
Organ System: Cardiac disorders
Frequency: 37 affected / 576 at risk

Adverse event: Death- Cardiovascular/Unexplained
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 576 at risk

Adverse event: Death- Cardiovascular/Unexplained
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 576 at risk

Adverse event: Death- Cardiovascular/Unexplained
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 576 at risk

Adverse event: Death- Cardiovascular/Unexplained
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 576 at risk

Adverse event: Death- Cardiovascular/Unexplained
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 576 at risk

Adverse event: Death- Cardiovascular/Unexplained
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 576 at risk

Adverse event: Death- Cardiovascular/Unexplained
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 576 at risk

Adverse event: Device Thrombus (thrombus on the atrial facing side of the device)
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 576 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 576 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 576 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 576 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 576 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 576 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 576 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 576 at risk

Adverse event: Infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 576 at risk

Adverse event: Major Bleed Requiring Transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 576 at risk

Adverse event: Major Bleed Requiring Transfusion
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 576 at risk

Adverse event: Major Bleed Requiring Transfusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 576 at risk

Adverse event: Major Bleed Requiring Transfusion
Serious: yes
Organ System: Vascular disorders
Frequency: 19 affected / 576 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 576 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 576 at risk

Adverse event: Oral Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Oral Bleeding
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Other (Non-Study Related)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 576 at risk

Adverse event: Other (Non-Study Related)
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 576 at risk

Adverse event: Other (Non-Study Related)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 576 at risk

Adverse event: Other (Non-Study Related)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 576 at risk

Adverse event: Other (Non-Study Related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 576 at risk

Adverse event: Other (Non-Study Related)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 576 at risk

Adverse event: Other (Non-Study Related)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 576 at risk

Adverse event: Other (Non-Study Related)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 576 at risk

Adverse event: Other (Non-Study Related)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Other (Non-Study Related)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 576 at risk

Adverse event: Other (Study Related)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 576 at risk

Adverse event: Other (Study Related)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 576 at risk

Adverse event: Other (Study Related)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 576 at risk

Adverse event: Other (Study Related)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 576 at risk

Adverse event: Other (Study Related)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Other (Study Related)
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 576 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 576 at risk

Adverse event: Pericardial Effusion with Cardiac Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 576 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 576 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 576 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 576 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 576 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 576 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 576 at risk

Adverse event: Stroke (Hemorrhagic)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 576 at risk

Adverse event: Stroke (Ischemic)
Serious: yes
Organ System: Nervous system disorders
Frequency: 43 affected / 576 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 576 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 576 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 576 at risk

Adverse event: Embolism arterial
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Embolism arterial
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 576 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 576 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 576 at risk

Adverse event: Valvular Damage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 576 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 576 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 576 at risk

Adverse event: Anemia Requiring Transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 576 at risk

Adverse event: Anemia Requiring Transfusion
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 576 at risk

Adverse event: Device Thrombus (thrombus on the atrial facing side of the device)
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 576 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 576 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 576 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 576 at risk

Adverse event: Other (Study Related)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 576 at risk

Adverse event: Other (Study Related)
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 576 at risk

Adverse event: Other (Study Related)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 576 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 576 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 576 at risk

Adverse event: Stroke (Ischemic)
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 576 at risk

Adverse event: Stroke (Ischemic)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 576 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 576 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 576 at risk