Study: NCT01675596

Adverse event: Abnormal lab value
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 199 at risk

Adverse event: Access site and access related vascular injury - Dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 199 at risk

Adverse event: Access site and access related vascular injury - Distal embolization (noncerebral)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Access site and access related vascular injury - Distal embolization (noncerebral) from vascular source
Frequency: 1 affected / 199 at risk

Adverse event: Access site and access related vascular injury - Failure of percutaneous access site closure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Access site and access related vascular injury - Failure of percutaneous access site closure resulting in intervention
Frequency: 2 affected / 199 at risk

Adverse event: Access site and access related vascular injury - Hematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 199 at risk

Adverse event: Access site and access related vascular injury - Pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 199 at risk

Adverse event: Access site and access related vascular injury - Rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 199 at risk

Adverse event: Access site and access related vascular injury - Ventricular rupture (Apical rupture)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 199 at risk

Adverse event: Anemia/Hemolytic anemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 199 at risk

Adverse event: Angina/Cardiac chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 199 at risk

Adverse event: Arrhythmia/Conduction system injury (defect)
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 199 at risk

Adverse event: Bleeding - Hemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 199 at risk

Adverse event: Cardiac tamponade/Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 199 at risk

Adverse event: Device migration/malposition requiring intervention
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 199 at risk

Adverse event: Embolization including air/calcific valve material or Thrombus
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 199 at risk

Adverse event: Gastro Intestinal event - Non-hemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 199 at risk

Adverse event: Heart failure/CHF/Low output failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 199 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 199 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 199 at risk

Adverse event: Infection - Respiratory infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 199 at risk

Adverse event: Infection - Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 199 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 199 at risk

Adverse event: Mental state change (not neurological) - Confusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 199 at risk

Adverse event: Miscellaneous - Other
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 199 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 199 at risk

Adverse event: Neurological - Hemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 199 at risk

Adverse event: Neurological - Ischemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 199 at risk

Adverse event: Neurological - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 199 at risk

Adverse event: Neurological - Other new neurological sign consistent with stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 199 at risk

Adverse event: Neurological - TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 199 at risk

Adverse event: Renal insufficiency or renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 199 at risk

Adverse event: Respiratory event - Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 199 at risk

Adverse event: Respiratory event - Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 199 at risk

Adverse event: Respiratory event - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 199 at risk

Adverse event: Respiratory event - Pulmonary edema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 199 at risk

Adverse event: Respiratory event - Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 199 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 199 at risk

Adverse event: Death
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 199 at risk

Adverse event: Other
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 199 at risk

Adverse event: Genito-Urinary event - Non-hemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 199 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 199 at risk

Adverse event: Access site and access related vascular injury - Hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 51 affected / 199 at risk

Adverse event: Anemia/Hemolytic anemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 199 at risk

Adverse event: Arrhythmia/Conduction system injury (defect)
Serious: no
Organ System: Cardiac disorders
Frequency: 65 affected / 199 at risk

Adverse event: Bleeding - Hemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 58 affected / 199 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 28 affected / 199 at risk

Adverse event: Musculoskeletal - Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 199 at risk

Adverse event: Other
Serious: no
Organ System: Investigations
Frequency: 100 affected / 199 at risk

Adverse event: Abnormal Labs
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 199 at risk

Adverse event: Genito-Urinary event - Non-hemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 199 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 199 at risk

Adverse event: Infection - Respiratory infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 199 at risk

Adverse event: Mental state change (not neurological) - Confusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 199 at risk

Adverse event: Renal insufficiency or renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 199 at risk

Adverse event: Miscellaneous - Other
Serious: no
Organ System: General disorders
Frequency: 11 affected / 199 at risk