Study: NCT01396525

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Access Site Complication per Abbott Vascular (AV) Organ Systems
Frequency: 1 affected / 153 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Access Site Complication per Abbott Vascular (AV) Organ Systems
Frequency: 1 affected / 153 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 153 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 153 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 153 at risk

Adverse event: Arrhythmias (other than bradycardia)
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 153 at risk

Adverse event: Cardiac / Hemodynamic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 153 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 153 at risk

Adverse event: Myocardial Infarction - Non-Q- wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Myocardial Infarction - Q- wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Chest Pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Coronary Artery Disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 153 at risk

Adverse event: Pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 2 affected / 153 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 2 affected / 153 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 3 affected / 153 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 4 affected / 153 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 1 affected / 153 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 3 affected / 153 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 153 at risk

Adverse event: Gastro-intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 153 at risk

Adverse event: Infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 153 at risk

Adverse event: Other: Abdominal Pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 153 at risk

Adverse event: Other: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Diabetic Gastroparesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Duodenal Ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Incisional Hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 153 at risk

Adverse event: Surgery/Interventional Procedure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Gastro-intestinal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Other: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Other: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Other: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 153 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 153 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 153 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Wound complication or wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 153 at risk

Adverse event: Other: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Fatigue
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Hypocalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Hypokalemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Hyponatremia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 153 at risk

Adverse event: Edema (non pulmonary)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 153 at risk

Adverse event: Genito-urinary
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 153 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Acquired Spondylolistheses
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Frequent Falls
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Lethargy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Multi Organ Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Shingles
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Trauma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Surgery/Interventional Procedure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Myocardial Infarction - Non-Q- wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 153 at risk

Adverse event: Myocardial Infarction - Unknown
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 153 at risk

Adverse event: Other: Myocardial Infarction - Non-Q Wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Mental Status Change
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 3 affected / 153 at risk

Adverse event: Other: Anoxic Injury
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 1 affected / 153 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 1 affected / 153 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 4 affected / 153 at risk

Adverse event: Vision disturbance
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 1 affected / 153 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Non-Access Site Bleeding
Frequency: 1 affected / 153 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Non-Access Site Bleeding
Frequency: 1 affected / 153 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 153 at risk

Adverse event: Dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Procedure-related
Frequency: 2 affected / 153 at risk

Adverse event: Distal Emboli
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Procedure-related
Frequency: 1 affected / 153 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 153 at risk

Adverse event: Embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Pleural Effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 153 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 153 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Acute Exacerbation Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Shortness Of Breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 153 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 153 at risk

Adverse event: Viral, bacterial and fungal infections
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: CVA
Serious: yes
Organ System: Vascular disorders
Notes: Stroke
Frequency: 1 affected / 153 at risk

Adverse event: Other: Cerebral Vascular Accident
Serious: yes
Organ System: Vascular disorders
Notes: Stroke
Frequency: 2 affected / 153 at risk

Adverse event: Other: Lacunar Stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: Dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 153 at risk

Adverse event: Gastro-intestinal
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 153 at risk

Adverse event: Vascular occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 153 at risk

Adverse event: Other: Aortic Iliac
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Carotid Artery Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: Other: Deep Vein Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 153 at risk

Adverse event: Other: Peripheral Vascular Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 153 at risk

Adverse event: Other: Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: Pain
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: Renal
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: Restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 153 at risk

Adverse event: Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 25 affected / 153 at risk

Adverse event: Vascular stent thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 153 at risk

Adverse event: Surgery/Interventional Procedure
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 153 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 153 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 153 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 8 affected / 153 at risk

Adverse event: Edema (non pulmonary)
Serious: no
Organ System: General disorders
Frequency: 13 affected / 153 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 48 affected / 153 at risk

Adverse event: Other: Shortness Of Breath
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 153 at risk

Adverse event: Other: Peripheral Vascular Disease
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 153 at risk

Adverse event: Stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 153 at risk