Study: NCT01182441

Adverse event: AV fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 269 at risk

Adverse event: Anemia requiring transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 269 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Cranial bleed
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 269 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 36 affected / 269 at risk

Adverse event: Device embolisation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 269 at risk

Adverse event: Device thrombus
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 269 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 269 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 269 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 269 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 269 at risk

Adverse event: Major bleeding requiring transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 269 at risk

Adverse event: Other study related
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 269 at risk

Adverse event: Pericardial effusion with cardiac tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 269 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 269 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 269 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 269 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 269 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 269 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 269 at risk

Adverse event: Embolism arterial
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 269 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 269 at risk

Adverse event: Anemia requiring transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 269 at risk

Adverse event: Device thrombus
Serious: no
Organ System: General disorders
Frequency: 15 affected / 269 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 269 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 269 at risk

Adverse event: Haematuria
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Oral bleeding
Serious: no
Organ System: General disorders
Frequency: 2 affected / 269 at risk

Adverse event: Other study related
Serious: no
Organ System: General disorders
Frequency: 2 affected / 269 at risk

Adverse event: Pericardial effusion, non-serious
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 269 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 269 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 269 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 269 at risk

Adverse event: Bleeding, other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 138 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 24 affected / 138 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 138 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 138 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 138 at risk

Adverse event: Major bleeding requiring transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 138 at risk

Adverse event: Other study related
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 138 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 138 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 138 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 138 at risk

Adverse event: Bleeding, other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 138 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 138 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 138 at risk

Adverse event: Haematuria
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 138 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 138 at risk