Study: NCT02097420

Adverse event: Abnormal Coagulation Parameter
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Anemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 23 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: LVOT Resection with Resection of Subaortic Membrane Myotomy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Left Ventricle Outflow Tract Observation w/ Subaortic Obstruction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Moderate Left Ventricular (LV) Dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pseudoaneurysm on Left Ventricular Free Wall
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Third Degree Heart Block (Complete Heart Block)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 23 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 23 at risk

Adverse event: Perivalvular Leak
Serious: yes
Organ System: General disorders
Notes: Valve related adverse event
Frequency: 1 affected / 23 at risk

Adverse event: Bacterial Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Common Cold/Upper Respiratory Tract Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Septic Shock Related to Presumed Pneumotosis/Nec
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Abnormal Chest X-Ray
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Abnormal Lab Value
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Respiratory acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Generalized Tonic-Clonic Seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Prosthetic Mitral Valve Dysfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 23 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 23 at risk

Adverse event: Thrombus on Device
Serious: yes
Organ System: Product Issues
Notes: Valve related adverse event
Frequency: 3 affected / 23 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: G-Tube Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 23 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Vascular disorders
Notes: Valve related adverse event
Frequency: 1 affected / 23 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Valve related adverse event
Frequency: 1 affected / 23 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 23 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 23 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Valve related adverse event
Frequency: 1 affected / 23 at risk

Adverse event: Intraparenchymal Haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Valve related adverse event
Frequency: 1 affected / 23 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Valve related adverse event
Frequency: 1 affected / 23 at risk

Adverse event: Abnormal Coagulation Parameter
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Anemias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 23 at risk

Adverse event: Augmentation of Ascending Aorta with Pulmonary Homograft
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Elevated RV Pressure and Pulmonary Vasculature Resistance
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Infective/Bacterial Endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Junctional Escape Rhythm/Intermittent Junctional Rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: LVOT Resection
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Mitral valve stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Progressive LVOT Obstruction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: ST Segment Changes
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Sinus node dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Third Degree Heart Block (Complete Heart Block)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Valve Stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 23 at risk

Adverse event: Common Cold/Upper Respiratory Tract Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Abnormal Lab Value
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Elevated ALT Levels
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Elevated AST Levels
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Elevated Plasma Free Hemoglobin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Elective procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 23 at risk

Adverse event: Elective surgery
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 23 at risk

Adverse event: Reoperation for Subaortic Stenosis
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 23 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 23 at risk

Adverse event: Cardiogenic shock
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 23 at risk