Study: NCT01931956

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 59 at risk

Adverse event: Hematologic - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 59 at risk

Adverse event: Infection
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 59 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 59 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Cardiac : other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 59 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 59 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Lead displacement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 59 at risk

Adverse event: Other rhythm disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 59 at risk

Adverse event: Residual/Recurrent MR
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 59 at risk

Adverse event: Syncope/Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: GI related - bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 59 at risk

Adverse event: GI related - infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 59 at risk

Adverse event: GI related - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 59 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 34 affected / 59 at risk

Adverse event: Generalized weakness/fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Metabolic/endocrine disorders : Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 59 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: infection : Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 59 at risk

Adverse event: Connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 59 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Neurologic - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 59 at risk

Adverse event: Mental disorders : Other
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 59 at risk

Adverse event: Renal - infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 59 at risk

Adverse event: Renal - other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 59 at risk

Adverse event: Renal - renal insufficiency/failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 59 at risk

Adverse event: Bronchial/lung disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Chronic obstructive pulmonary diseas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 59 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 59 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 59 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Respiratory - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 59 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 59 at risk

Adverse event: Bleeding complication
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 59 at risk

Adverse event: Blood pressure complication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 59 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 59 at risk

Adverse event: Embolization
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 59 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 59 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 59 at risk

Adverse event: Injury
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 59 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 59 at risk

Adverse event: Vascular - other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 59 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 59 at risk

Adverse event: Infection/Bacteremia/Septicemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 59 at risk

Adverse event: Atrial septal defect
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: Bradyarrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 59 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Chest Pain/Angina
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 59 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 59 at risk

Adverse event: Lead Displacement
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Mitral valve stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Other
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 59 at risk

Adverse event: Other Rhythm Disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 59 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 59 at risk

Adverse event: Residual/Recurrent MR
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 59 at risk

Adverse event: Syncope/Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 59 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Bleed
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Death
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Generalized Weakness/Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 4 affected / 59 at risk

Adverse event: Mental Disorders
Serious: no
Organ System: General disorders
Frequency: 2 affected / 59 at risk

Adverse event: Metabolic/Endocrine Disorders
Serious: no
Organ System: General disorders
Frequency: 5 affected / 59 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 7 affected / 59 at risk

Adverse event: Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 59 at risk

Adverse event: Other
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 59 at risk

Adverse event: Infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 59 at risk

Adverse event: Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 59 at risk

Adverse event: Renal Insufficiency/Failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 59 at risk

Adverse event: Bronchial/Lung Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 59 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 59 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 59 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: AV fistula
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 59 at risk

Adverse event: Aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 59 at risk

Adverse event: Bleeding Complication
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 59 at risk

Adverse event: Blood Pressure Complication
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 59 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 59 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 59 at risk

Adverse event: Haemodynamic instability
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 59 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Infection
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cardiac : other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 7 at risk

Adverse event: Residual/Recurrent MR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: GI related - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 7 at risk

Adverse event: Renal - renal insufficiency/failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Respiratory - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Infection/Bacteremia/Septicemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Bradyarrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Mitral Valve Injury
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Residual/Recurrent MR
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: SLDA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Delirium
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Other
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Haemodynamic instability
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 49 affected / 628 at risk

Adverse event: Hematologic - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 628 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 43 affected / 628 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 628 at risk

Adverse event: Cardiac : other
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 628 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 43 affected / 628 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 628 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 628 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 31 affected / 628 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 232 affected / 628 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 628 at risk

Adverse event: Lead displacement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 628 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 628 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 628 at risk

Adverse event: Other rhythm disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 628 at risk

Adverse event: Residual/Recurrent MR
Serious: yes
Organ System: Cardiac disorders
Frequency: 35 affected / 628 at risk

Adverse event: Syncope/Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 628 at risk

Adverse event: Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 628 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 628 at risk

Adverse event: GI related - bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 628 at risk

Adverse event: GI related - infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 628 at risk

Adverse event: GI related - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 65 affected / 628 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 352 affected / 628 at risk

Adverse event: Generalized weakness/fatigue
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 628 at risk

Adverse event: Metabolic/endocrine disorders : Other
Serious: yes
Organ System: General disorders
Frequency: 41 affected / 628 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 73 affected / 628 at risk

Adverse event: infection : Other
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 628 at risk

Adverse event: Connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 57 affected / 628 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 15 affected / 628 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 628 at risk

Adverse event: Neurologic - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 20 affected / 628 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 23 affected / 628 at risk

Adverse event: Renal - infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 20 affected / 628 at risk

Adverse event: Renal - other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 23 affected / 628 at risk

Adverse event: Renal - renal insufficiency/failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 78 affected / 628 at risk

Adverse event: Bronchial/lung disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 628 at risk

Adverse event: Chronic obstructive pulmonary diseas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 628 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 628 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 63 affected / 628 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 628 at risk

Adverse event: Respiratory - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 628 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 56 affected / 628 at risk

Adverse event: Bleeding complication
Serious: yes
Organ System: Vascular disorders
Frequency: 32 affected / 628 at risk

Adverse event: Blood pressure complication
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 628 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 628 at risk

Adverse event: Embolization
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 628 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 628 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: Vascular disorders
Frequency: 28 affected / 628 at risk

Adverse event: Injury
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 628 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 628 at risk

Adverse event: Vascular - other
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 628 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 628 at risk

Adverse event: Infection/bacteremia/septicemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 45 affected / 628 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 628 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 628 at risk

Adverse event: Skin/mucosal/subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 628 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 628 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 628 at risk

Adverse event: Infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 628 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 628 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 628 at risk

Adverse event: AV fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 628 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 628 at risk

Adverse event: Bruise/contusion/ecchymosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 628 at risk

Adverse event: Retroperitoneal haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 628 at risk

Adverse event: Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 628 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 26 affected / 628 at risk

Adverse event: MV Surgery
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 628 at risk

Adverse event: SLDA
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 628 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 628 at risk

Adverse event: Heart transplant
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 628 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 628 at risk

Adverse event: Mitral valve injury
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 628 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 628 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 628 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 628 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 628 at risk

Adverse event: Supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 628 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 628 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 628 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 628 at risk

Adverse event: Bradyarrythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 628 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 69 affected / 628 at risk

Adverse event: Infection/Bacteremia/Septicemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 628 at risk

Adverse event: Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 628 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 628 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 60 affected / 628 at risk

Adverse event: Atrial septal defect
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 628 at risk

Adverse event: Bradyarrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 628 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 628 at risk

Adverse event: Chest Pain/Angina
Serious: no
Organ System: Cardiac disorders
Frequency: 37 affected / 628 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 64 affected / 628 at risk

Adverse event: Lead Displacement
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 628 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 628 at risk

Adverse event: Mitral valve stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 628 at risk

Adverse event: Mitral Valve Injury
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 628 at risk

Adverse event: Other
Serious: no
Organ System: Cardiac disorders
Frequency: 43 affected / 628 at risk

Adverse event: Other Rhythm Disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 628 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 628 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 628 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 33 affected / 628 at risk

Adverse event: Residual/Recurrent MR
Serious: no
Organ System: Cardiac disorders
Frequency: 103 affected / 628 at risk

Adverse event: SLDA
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 628 at risk

Adverse event: Syncope/Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 628 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 628 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 628 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 628 at risk

Adverse event: Bleed
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 628 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 628 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 628 at risk

Adverse event: Death
Serious: no
Organ System: General disorders
Frequency: 3 affected / 628 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 628 at risk

Adverse event: Generalized Weakness/Fatigue
Serious: no
Organ System: General disorders
Frequency: 51 affected / 628 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 18 affected / 628 at risk

Adverse event: Mental Disorders
Serious: no
Organ System: General disorders
Frequency: 14 affected / 628 at risk

Adverse event: Metabolic/Endocrine Disorders
Serious: no
Organ System: General disorders
Frequency: 70 affected / 628 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 141 affected / 628 at risk

Adverse event: Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 91 affected / 628 at risk

Adverse event: Other
Serious: no
Organ System: Nervous system disorders
Frequency: 53 affected / 628 at risk

Adverse event: Infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 53 affected / 628 at risk

Adverse event: Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 58 affected / 628 at risk

Adverse event: Renal Insufficiency/Failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 66 affected / 628 at risk

Adverse event: Bronchial/Lung Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 628 at risk

Adverse event: Infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 628 at risk

Adverse event: Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 115 affected / 628 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 628 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 628 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 628 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 628 at risk

Adverse event: AV fistula
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 628 at risk

Adverse event: Aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 628 at risk

Adverse event: Bleeding Complication
Serious: no
Organ System: Vascular disorders
Frequency: 75 affected / 628 at risk

Adverse event: Blood Pressure Complication
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 628 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 628 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 55 affected / 628 at risk

Adverse event: Haemodynamic instability
Serious: no
Organ System: Vascular disorders
Frequency: 71 affected / 628 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 628 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 628 at risk

Adverse event: Endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 628 at risk

Adverse event: Atrioventricular block
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 628 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 628 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 628 at risk

Adverse event: Supraventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 628 at risk

Adverse event: Surgery
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 628 at risk

Adverse event: Infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 628 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 628 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 628 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 628 at risk

Adverse event: Cerebral haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 628 at risk

Adverse event: Ischaemic stroke
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 628 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 628 at risk

Adverse event: Incisional site pain
Serious: no
Organ System: General disorders
Frequency: 20 affected / 628 at risk

Adverse event: Skin/mucosal/subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 628 at risk

Adverse event: Chronic Obstructive Pulmonary Disease (COPD)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 628 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 628 at risk

Adverse event: Peripheral ischaemia
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 628 at risk

Adverse event: Bruise/contusion/ecchymosis
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 628 at risk

Adverse event: Injury
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 628 at risk

Adverse event: Other
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 628 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 628 at risk

Adverse event: Thrombosis/Thromboembolism
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 628 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 628 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 271 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 35 affected / 271 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 271 at risk

Adverse event: Cardiac : other
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 271 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 271 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 271 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 271 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 271 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 63 affected / 271 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 271 at risk

Adverse event: Lead displacement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 271 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 271 at risk

Adverse event: Other rhythm disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 271 at risk

Adverse event: Residual/Recurrent MR
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 271 at risk

Adverse event: Syncope/Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 271 at risk

Adverse event: Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 271 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 271 at risk

Adverse event: GI related - bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 271 at risk

Adverse event: GI related - infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 271 at risk

Adverse event: GI related - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 271 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 95 affected / 271 at risk

Adverse event: Generalized weakness/fatigue
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 271 at risk

Adverse event: Metabolic/endocrine disorders : Other
Serious: yes
Organ System: General disorders
Frequency: 24 affected / 271 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 34 affected / 271 at risk

Adverse event: infection : Other
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 271 at risk

Adverse event: Connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 271 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 271 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 271 at risk

Adverse event: Neurologic - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 271 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 16 affected / 271 at risk

Adverse event: Renal - infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 271 at risk

Adverse event: Renal - other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 271 at risk

Adverse event: Renal - renal insufficiency/failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 25 affected / 271 at risk

Adverse event: Bronchial/lung disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 271 at risk

Adverse event: Chronic obstructive pulmonary diseas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 271 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 271 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 271 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 271 at risk

Adverse event: Respiratory - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 271 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 271 at risk

Adverse event: Bleeding complication
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 271 at risk

Adverse event: Blood pressure complication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 271 at risk

Adverse event: Embolization
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 271 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 271 at risk

Adverse event: Injury
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Vascular - other
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 271 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 271 at risk

Adverse event: Infection/bacteremia/septicemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 271 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 271 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 271 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 271 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 271 at risk

Adverse event: AV fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 271 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 271 at risk

Adverse event: Retroperitoneal haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 271 at risk

Adverse event: MV Surgery
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 271 at risk

Adverse event: SLDA
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 271 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 271 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 271 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 271 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Bradyarrythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 271 at risk

Adverse event: Emergent MV surgery
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 271 at risk

Adverse event: Hematologic-Shock
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 271 at risk

Adverse event: Mesentric Ischemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 271 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 271 at risk

Adverse event: Infection/Bacteremia/Septicemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 271 at risk

Adverse event: Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 271 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 271 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 271 at risk

Adverse event: Atrial septal defect
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 271 at risk

Adverse event: Bradyarrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 271 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 271 at risk

Adverse event: Chest Pain/Angina
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 271 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 271 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 271 at risk

Adverse event: Mitral valve stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 271 at risk

Adverse event: Other
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 271 at risk

Adverse event: Other Rhythm Disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 271 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 271 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 271 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 271 at risk

Adverse event: Residual/Recurrent MR
Serious: no
Organ System: Cardiac disorders
Frequency: 55 affected / 271 at risk

Adverse event: SLDA
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 271 at risk

Adverse event: Syncope/Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 271 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 271 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 271 at risk

Adverse event: Bleed
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 271 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 271 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 271 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 271 at risk

Adverse event: Generalized Weakness/Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 271 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 7 affected / 271 at risk

Adverse event: Mental Disorders
Serious: no
Organ System: General disorders
Frequency: 6 affected / 271 at risk

Adverse event: Metabolic/Endocrine Disorders
Serious: no
Organ System: General disorders
Frequency: 35 affected / 271 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 62 affected / 271 at risk

Adverse event: Connective Tissue Disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 271 at risk

Adverse event: Other
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 271 at risk

Adverse event: Infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 18 affected / 271 at risk

Adverse event: Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 22 affected / 271 at risk

Adverse event: Renal Insufficiency/Failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 26 affected / 271 at risk

Adverse event: Bronchial/Lung Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 271 at risk

Adverse event: Infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 271 at risk

Adverse event: Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 66 affected / 271 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 271 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 271 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 271 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 271 at risk

Adverse event: AV fistula
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 271 at risk

Adverse event: Aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Bleeding Complication
Serious: no
Organ System: Vascular disorders
Frequency: 29 affected / 271 at risk

Adverse event: Blood Pressure Complication
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 271 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 271 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 271 at risk

Adverse event: Haemodynamic instability
Serious: no
Organ System: Vascular disorders
Frequency: 28 affected / 271 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Atrioventricular block
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 271 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 271 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 271 at risk

Adverse event: Supraventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 271 at risk

Adverse event: Infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 271 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 271 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 271 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 271 at risk

Adverse event: Incisional site pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 271 at risk

Adverse event: Skin/mucosal/subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 271 at risk

Adverse event: Chronic Obstructive Pulmonary Disease (COPD)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 271 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 271 at risk

Adverse event: Peripheral ischaemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Bruise/contusion/ecchymosis
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 271 at risk

Adverse event: Other
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 271 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 271 at risk

Adverse event: Thrombosis/Thromboembolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: Retroperitoneal haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 271 at risk

Adverse event: MV surgery
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 271 at risk