Study: NCT01541865

Adverse event: Access Site Infection
Serious: yes
Organ System: Surgical and medical procedures
Notes: Procedure Related
Frequency: 2 affected / 146 at risk

Adverse event: Clot or Thrombus Formation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Procedure Related
Frequency: 1 affected / 146 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Surgical and medical procedures
Notes: Procedure Related
Frequency: 1 affected / 146 at risk

Adverse event: Other Vascular - Stenosis
Serious: yes
Organ System: Surgical and medical procedures
Notes: Device Related/Procedure Related
Frequency: 1 affected / 146 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Surgical and medical procedures
Notes: Procedure Related
Frequency: 1 affected / 146 at risk

Adverse event: Other - Flank Pain
Serious: yes
Organ System: Surgical and medical procedures
Notes: Procedure Related
Frequency: 1 affected / 146 at risk

Adverse event: Other - Digestive (vomiting)
Serious: yes
Organ System: Surgical and medical procedures
Notes: Procedure Related
Frequency: 1 affected / 146 at risk

Adverse event: Other - Hypertensive Crisis
Serious: yes
Organ System: Surgical and medical procedures
Notes: Device Related/Procedure Related
Frequency: 4 affected / 146 at risk

Adverse event: Other Cardiac - Hypertensive episode
Serious: yes
Organ System: Surgical and medical procedures
Notes: Device Related
Frequency: 1 affected / 146 at risk

Adverse event: Acute Occlusion/Vessel Closure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 146 at risk

Adverse event: Stent Required
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 146 at risk

Adverse event: Other Vascular - Carotid Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 146 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 146 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 146 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 146 at risk

Adverse event: Other Renal - Renal Calcification
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 146 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 146 at risk

Adverse event: Other Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 146 at risk

Adverse event: Other Infectious/Inflammatory
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 146 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 146 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 146 at risk

Adverse event: Other Neurological
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 146 at risk

Adverse event: Unanticipated Adverse Events - Prolapsis Uteri
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 146 at risk

Adverse event: Other Cardiac - Chest Pain/Angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 146 at risk

Adverse event: Other - Hypertension
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 13 affected / 146 at risk

Adverse event: Other Cardiac - Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 146 at risk

Adverse event: Other Cardiac - Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 146 at risk

Adverse event: Other - Inflammation/Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 146 at risk

Adverse event: Other - Thoracic/Abdominal Pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 146 at risk

Adverse event: Other - Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 146 at risk

Adverse event: Other - Gastrointestinal/Rectal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 146 at risk

Adverse event: Other - Skeletal/Connective Tissue
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 146 at risk

Adverse event: Other - Deconditioning post medical illness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 146 at risk

Adverse event: Other - Dementia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 146 at risk

Adverse event: Other - Diabetes
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 146 at risk

Adverse event: Other - Elective Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 146 at risk

Adverse event: Other - Priapismus
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 146 at risk

Adverse event: Other - Limb oedema/ Ulceration
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 146 at risk

Adverse event: Other - Coronary Sub-Occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 146 at risk

Adverse event: Other - Nausea
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 146 at risk

Adverse event: Other - Overdose
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 146 at risk

Adverse event: Other - Prostate Carcinoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 146 at risk

Adverse event: Other - Sleep Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 146 at risk

Adverse event: Other - Suicide Ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 146 at risk

Adverse event: Access Site Complications
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Procedure Related
Frequency: 20 affected / 146 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 23 affected / 146 at risk

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Procedure Related
Frequency: 18 affected / 146 at risk

Adverse event: Anaesthesia Related - Nausea/Vomiting
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 12 affected / 146 at risk

Adverse event: Reduced Kidney Function
Serious: no
Organ System: Renal and urinary disorders
Notes: Device Related
Frequency: 9 affected / 146 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Potentially Related to Device and/or Procedure
Frequency: 16 affected / 146 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Notes: Potentially Related to Device and/or Procedure
Frequency: 14 affected / 146 at risk