Study: NCT00820599

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 211 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 211 at risk

Adverse event: Annular Dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 211 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 211 at risk

Adverse event: Aortic Regurgitation ( 3+ 0r 4+)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 211 at risk

Adverse event: Arrhythmia and Pacemaker Implant
Serious: yes
Organ System: Cardiac disorders
Frequency: 31 affected / 211 at risk

Adverse event: Arrhythmia w/o Pacemaker Implant
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 211 at risk

Adverse event: Bleeding Event Major - Not Surgical
Serious: yes
Organ System: Vascular disorders
Frequency: 19 affected / 211 at risk

Adverse event: Bleeding Event Minor - Not Surgical
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 211 at risk

Adverse event: Bone Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 24 affected / 211 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 16 affected / 211 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 211 at risk

Adverse event: Circulatory Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 211 at risk

Adverse event: Coagulopathy / Hematological Disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 211 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 130 affected / 211 at risk

Adverse event: Drug Reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 211 at risk

Adverse event: Embolism - Not Stroke - Not TE
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 211 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 211 at risk

Adverse event: Explant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 211 at risk

Adverse event: Fever Unknown Origin
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 211 at risk

Adverse event: Gastro-Intestinal Compl
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 211 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 70 affected / 211 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 211 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 211 at risk

Adverse event: Infection / Inflammation
Serious: yes
Organ System: Infections and infestations
Frequency: 45 affected / 211 at risk

Adverse event: Metabolic Complication
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 211 at risk

Adverse event: Mitral Regurg. ( 3+ or 4+)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Multiple Organ Comp/Failure
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 211 at risk

Adverse event: Myocardial Damage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 211 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 211 at risk

Adverse event: Neurological Event Minor - Not Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 211 at risk

Adverse event: Neurological Event Severe - Not Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 211 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 57 affected / 211 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 211 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 211 at risk

Adverse event: Perivalvular Leak (1+ or 2+)
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 211 at risk

Adverse event: Perivalvular Leak (3+ or 4+)
Serious: yes
Organ System: Product Issues
Frequency: 7 affected / 211 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 211 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 211 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 211 at risk

Adverse event: Renal Comp / Failure Not Requiring Dialysis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 18 affected / 211 at risk

Adverse event: Renal Failure Requiring Dialysis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 211 at risk

Adverse event: Reoperation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 211 at risk

Adverse event: Respiratory Comp / Failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 211 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 211 at risk

Adverse event: Stroke - Bleeding Origin
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 211 at risk

Adverse event: Stroke - Embolic Origin
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 211 at risk

Adverse event: Stroke - Unknown Origin
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 211 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 211 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 211 at risk

Adverse event: Surgical Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 211 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 211 at risk

Adverse event: Thromboembolic Event Minor - Not Stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 211 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 211 at risk

Adverse event: Transitory Psychotic Syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 211 at risk

Adverse event: Tricuspid Regurg. ( 3+ or 4+)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 211 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 211 at risk

Adverse event: Valve Embolization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 211 at risk

Adverse event: Valve Malpositioned
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 211 at risk

Adverse event: Valve Migration
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 211 at risk

Adverse event: Vascular Access-Related Complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 24 affected / 211 at risk

Adverse event: Vascular Complication (Not Access-Related)
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 211 at risk

Adverse event: Vision Disorder
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 211 at risk

Adverse event: Arrhythmia w/o Pacemaker Implant
Serious: no
Organ System: Cardiac disorders
Frequency: 58 affected / 211 at risk

Adverse event: Bleeding Event Minor - Not Surgical
Serious: no
Organ System: Vascular disorders
Frequency: 42 affected / 211 at risk

Adverse event: Coagulopathy / Hematological Disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 51 affected / 211 at risk

Adverse event: Ecg Changes
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 211 at risk

Adverse event: Fever Unknown Origin
Serious: no
Organ System: General disorders
Frequency: 11 affected / 211 at risk

Adverse event: Gastro-Intestinal Compl
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 211 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 211 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 211 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 211 at risk

Adverse event: Infection / Inflammation
Serious: no
Organ System: Infections and infestations
Frequency: 72 affected / 211 at risk

Adverse event: Metabolic Complication
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 211 at risk

Adverse event: Neurological Event Minor - Not Stroke
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 211 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 105 affected / 211 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 21 affected / 211 at risk

Adverse event: Perivalvular Leak (1+ or 2+)
Serious: no
Organ System: Product Issues
Frequency: 21 affected / 211 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 211 at risk

Adverse event: Renal Comp / Failure Not Requiring Dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 32 affected / 211 at risk

Adverse event: Respiratory Comp / Failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 211 at risk

Adverse event: Transitory Psychotic Syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 211 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 211 at risk

Adverse event: Vascular Access-Related Complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 29 affected / 211 at risk

Adverse event: Vision Disorder
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 211 at risk