Study: NCT01238835

Adverse event: Access Related Complication - Thoracic
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 218 at risk

Adverse event: Access Related Complication - Ventricle
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 218 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 218 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 218 at risk

Adverse event: Annular Dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 218 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 218 at risk

Adverse event: Bleeding - Not Trauma Not Procedure
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 218 at risk

Adverse event: Bleeding - Procedure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 218 at risk

Adverse event: Bleeding - Trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 218 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 16 affected / 218 at risk

Adverse event: Coagulopathy / Hematological Disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 53 affected / 218 at risk

Adverse event: Conduction Defects w/o Permanent Pacemaker
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 218 at risk

Adverse event: Conduction Defects with Permanent Pacemaker
Serious: yes
Organ System: Cardiac disorders
Frequency: 32 affected / 218 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 218 at risk

Adverse event: Delivery System Malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 218 at risk

Adverse event: Drug Reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 218 at risk

Adverse event: Gastro-Intestinal Event
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 218 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 58 affected / 218 at risk

Adverse event: Hemodynamic Collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 218 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 218 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 218 at risk

Adverse event: Infection / Inflammation
Serious: yes
Organ System: Infections and infestations
Frequency: 62 affected / 218 at risk

Adverse event: Metabolic disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 218 at risk

Adverse event: Mitral Regurg. ( 3+ or 4+)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 218 at risk

Adverse event: Mitral Valve Compromise
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 218 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 218 at risk

Adverse event: Neurological Event Minor - Not Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 218 at risk

Adverse event: Neurological Event Severe - Not Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 218 at risk

Adverse event: Non-Struct Valve Dysf. (Not PVL)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Orthopedic Event
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 218 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 67 affected / 218 at risk

Adverse event: Perivalvular Leak (1+ or 2+)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 218 at risk

Adverse event: Perivalvular Leak (3+ or 4+)
Serious: yes
Organ System: Product Issues
Frequency: 7 affected / 218 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 218 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 218 at risk

Adverse event: Renal Failure requiring Permanent Dialysis (>30d)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 218 at risk

Adverse event: Renal Insufficency not requiring Dialysis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 17 affected / 218 at risk

Adverse event: Renal Insufficiency / Failure requiring Temporary Dialysis (< or = 30d)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 19 affected / 218 at risk

Adverse event: Respiratory Comp / Failure not requ. Resp Assistance
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 218 at risk

Adverse event: Respiratory Comp / Failure requ. Resp Assistance
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 218 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 17 affected / 218 at risk

Adverse event: Stroke - Embolic / Ischemic Origin
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 218 at risk

Adverse event: Stroke - Unknown Origin
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 218 at risk

Adverse event: Struct Valve Deterioration (SVD)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 218 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 218 at risk

Adverse event: Thoracic Wound Comp.
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 218 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 218 at risk

Adverse event: Transitory Psychotic Syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 9 affected / 218 at risk

Adverse event: Valve Embolization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 218 at risk

Adverse event: Vascular Event (Not Access-Related)
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 218 at risk

Adverse event: Ventricular / Myocardial Injury / Perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 218 at risk

Adverse event: Vision Disorder
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 218 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 64 affected / 218 at risk

Adverse event: Bleeding - Procedure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 218 at risk

Adverse event: Coagulopathy / Hematological Disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 218 at risk

Adverse event: Conduction Defects w/o Permanent Pacemaker
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 218 at risk

Adverse event: Gastro-Intestinal Event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 218 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 218 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 218 at risk

Adverse event: Infection / Inflammation
Serious: no
Organ System: Infections and infestations
Frequency: 94 affected / 218 at risk

Adverse event: Metabolic disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 218 at risk

Adverse event: Neurological Event Minor - Not Stroke
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 218 at risk

Adverse event: Orthopedic Event
Serious: no
Organ System: General disorders
Frequency: 16 affected / 218 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 122 affected / 218 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 218 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 30 affected / 218 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 130 affected / 218 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 218 at risk

Adverse event: Renal Insufficency not requiring Dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 36 affected / 218 at risk

Adverse event: Respiratory Comp / Failure not requ. Resp Assistance
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 218 at risk

Adverse event: Transitory Psychotic Syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 39 affected / 218 at risk