Study: NCT00129545

Adverse event: AV Fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 93 at risk

Adverse event: Bruising - Hematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 93 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 93 at risk

Adverse event: Cranial Bleed
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 93 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 93 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 93 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 93 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Major Bleed Requiring Transfusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 93 at risk

Adverse event: Other Study Related
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 93 at risk

Adverse event: Pericardial Effusion with Cardiac Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 93 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Stroke - Ischemic
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 93 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Device Thrombus
Serious: no
Organ System: Investigations
Frequency: 2 affected / 93 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 93 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Other Study Related
Serious: no
Organ System: Investigations
Frequency: 9 affected / 93 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 93 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Anemia Requiring Transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 463 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 463 at risk

Adverse event: AV Fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 463 at risk

Adverse event: Bleeding from Varicose Veins
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 463 at risk

Adverse event: Bruising - Hematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 463 at risk

Adverse event: Cardiac perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 463 at risk

Adverse event: Cranial Bleed
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 463 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 59 affected / 463 at risk

Adverse event: Device embolisation
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 463 at risk

Adverse event: Device Thrombus
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 463 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 463 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 463 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 463 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 463 at risk

Adverse event: Major Bleed Requiring Transfusion
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 463 at risk

Adverse event: Other Study Related
Serious: yes
Organ System: Investigations
Frequency: 17 affected / 463 at risk

Adverse event: Pericardial Effusion with Cardiac Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 463 at risk

Adverse event: Pericardial Effusion-Serious
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 463 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 463 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Stroke - Hemorrhagic
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 463 at risk

Adverse event: Stroke - Ischemic
Serious: yes
Organ System: Nervous system disorders
Frequency: 24 affected / 463 at risk

Adverse event: Systemic Embolization
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 463 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 463 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 463 at risk

Adverse event: Air embolism
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Allergic Reaction to Contrast Media
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Anemia Requiring Transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 463 at risk

Adverse event: AV Fistula
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 463 at risk

Adverse event: Bleeding from Varicose Veins
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 463 at risk

Adverse event: Bruising - Hematoma
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 463 at risk

Adverse event: Device Thrombus
Serious: no
Organ System: Investigations
Frequency: 14 affected / 463 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 463 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 463 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 463 at risk

Adverse event: Inability to Move or Retrieve Device
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Oral Bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 463 at risk

Adverse event: Other Non-Study Related
Serious: no
Organ System: General disorders
Frequency: 2 affected / 463 at risk

Adverse event: Other Study Related
Serious: no
Organ System: Investigations
Frequency: 19 affected / 463 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 463 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 463 at risk

Adverse event: Stroke - Ischemic
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 463 at risk

Adverse event: Vasovagal Reactions
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Anemia Requiring Transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Cranial Bleed
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 244 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 44 affected / 244 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 244 at risk

Adverse event: Major Bleed Requiring Transfusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 244 at risk

Adverse event: Oral Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Other Study Related
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 244 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Stroke - Hemorrhagic
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 244 at risk

Adverse event: Stroke - Ischemic
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 244 at risk

Adverse event: Anemia Requiring Transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Bruising - Hematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 244 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 244 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 244 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 244 at risk

Adverse event: Oral Bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Other Study Related
Serious: no
Organ System: Investigations
Frequency: 2 affected / 244 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 244 at risk