Study: NCT02432196

Adverse event: Arrhythmia - Persistent atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 26 at risk

Adverse event: ePTFE cordal rupture
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 26 at risk

Adverse event: Nonspecific, unknown, or other body system - Other complication
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Biliary (gallbladder)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: CARDIOVASCULAR - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Bleeding - Gastrointestinal lower - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Bone fracture/Break
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Development of regurgitation as a result of technical errors
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 26 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Muscular skeletal/Dermatologic - Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pleural effusion - Left
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Sternal wound/Thoracic infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: RENAL FAILURE - CHRONIC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: VASCULAR - DEEP VEIN THROMBOSIS (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nonspecific, unknown, or other body system - Other complication
Serious: no
Organ System: General disorders
Frequency: 10 affected / 26 at risk

Adverse event: Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 26 at risk

Adverse event: Muscular skeletal/Dermatologic - Other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 26 at risk

Adverse event: Arrhythmia - Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: Anemia - Bleeding related - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Arrhythmia - Tachy-bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Bleeding - Pulmonary/Respiratory - Minor (e.g. hemothorax)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Cardiovascular - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: Damage to the native mitral valve apparatus Chord
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 26 at risk

Adverse event: Hypertension - Systemic
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 26 at risk

Adverse event: Renal dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: BLEEDING - CARDIOVASCULAR - MINOR
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: ANGINA, STABLE
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: THROMBOEMBOLIC EVENT - STROKE
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: EPTFE CORDAL RUPTURE
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 26 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: GENITOURINARY - OTHER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: URINARY TRACT INFECTION (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: ALLERGIC REACTION - OTHER
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: CANCER - NEWLY DIAGNOSED
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: RESPIRATORY INFECTION - UPPER (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk