Study: NCT03173534

Adverse event: Cardiac - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 172 at risk

Adverse event: Bleeding - Event Associated with bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Event associated with bleeding
Frequency: 26 affected / 172 at risk

Adverse event: Cardiac - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Notes: Heart Failure
Frequency: 7 affected / 172 at risk

Adverse event: Renal - Other (not bleeding)
Serious: yes
Organ System: Renal and urinary disorders
Notes: Other- not bleeding
Frequency: 6 affected / 172 at risk

Adverse event: Infection - Other (except endocarditis and device infection)
Serious: yes
Organ System: Infections and infestations
Notes: Other (except endocarditis and device infection)
Frequency: 7 affected / 172 at risk

Adverse event: Cardiac - Sudden Cardiac Death/Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Sudden Cardiac Death/Cardiac Arrest
Frequency: 8 affected / 172 at risk

Adverse event: Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 172 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not associated with bleeding
Frequency: 6 affected / 172 at risk

Adverse event: Cancer/Malignancy
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 172 at risk

Adverse event: Pulmonary - Respiratory Failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 172 at risk

Adverse event: Neurologic - Ischemic Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 172 at risk

Adverse event: Pulmonary - Pleural Effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pleural Effusion (not sanguineous)
Frequency: 3 affected / 172 at risk

Adverse event: Neurologic - Other
Serious: yes
Organ System: Nervous system disorders
Notes: Other
Frequency: 4 affected / 172 at risk

Adverse event: Neurologic - Stroke Type Unknown
Serious: yes
Organ System: Nervous system disorders
Notes: Stroke Type Unknown
Frequency: 5 affected / 172 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 172 at risk

Adverse event: Renal - AKI (requiring dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 172 at risk

Adverse event: Cardiac - Pericardial Effusion (not hemorrhagic)
Serious: yes
Organ System: Cardiac disorders
Notes: Pericardial Effusion (not hemorrhagic)
Frequency: 3 affected / 172 at risk

Adverse event: COVID-19 Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 172 at risk

Adverse event: Rehospitalization related to TAVR device or procedure
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 172 at risk

Adverse event: Infection - UTI
Serious: yes
Organ System: Infections and infestations
Notes: UTI
Frequency: 2 affected / 172 at risk

Adverse event: Thrombosis - Other systemic
Serious: yes
Organ System: Vascular disorders
Notes: Other systemic (other than stroke)
Frequency: 1 affected / 172 at risk

Adverse event: Cardiac - Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 172 at risk

Adverse event: COD Unknown
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 172 at risk

Adverse event: Neurologic - TIA
Serious: yes
Organ System: Nervous system disorders
Notes: TIA
Frequency: 2 affected / 172 at risk

Adverse event: Cardiac - Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 172 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other
Frequency: 2 affected / 172 at risk

Adverse event: Cardiac - AV Regurgitation/Leak
Serious: yes
Organ System: Cardiac disorders
Notes: AV Regurgitation/Leak
Frequency: 2 affected / 172 at risk

Adverse event: Septic shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 172 at risk

Adverse event: Endocrine Disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 172 at risk

Adverse event: Cardiac - Angina/Chest Pain/CAD
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 172 at risk

Adverse event: Pulmonary - Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonia
Frequency: 2 affected / 172 at risk

Adverse event: Pulmonary - COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: COPD
Frequency: 1 affected / 172 at risk

Adverse event: Neurologic - Subdural Hematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 172 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Notes: Requires endovascular repair
Frequency: 1 affected / 172 at risk

Adverse event: Vascular AV Fistula (intervention required)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 172 at risk

Adverse event: Cardiac - Heart Valve Damage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 172 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 172 at risk

Adverse event: Cardiac - Heart Valve Damage
Serious: yes
Organ System: Cardiac disorders
Notes: Heart Valve Damage
Frequency: 1 affected / 172 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Event Associated with bleeding
Frequency: 54 affected / 172 at risk

Adverse event: Cardiac - Other
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac- Other
Frequency: 40 affected / 172 at risk

Adverse event: Rental
Serious: no
Organ System: Renal and urinary disorders
Notes: Other- not bleeding
Frequency: 6 affected / 172 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 10 affected / 172 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Other (except endocarditis and device infection)
Frequency: 11 affected / 172 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not associated with bleeding
Frequency: 12 affected / 172 at risk

Adverse event: Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure
Serious: no
Organ System: General disorders
Notes: Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure
Frequency: 8 affected / 172 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Notes: Other
Frequency: 8 affected / 172 at risk

Adverse event: Infection - UTI
Serious: no
Organ System: Renal and urinary disorders
Notes: UTI
Frequency: 6 affected / 172 at risk

Adverse event: Cancer/Malignancy
Serious: no
Organ System: General disorders
Frequency: 5 affected / 172 at risk

Adverse event: Cardiac - Sudden Cardiac Death/Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac - Sudden Cardiac Death/Cardiac Arrest
Frequency: 9 affected / 172 at risk

Adverse event: Neurologic - Ischemic Stroke
Serious: no
Organ System: Nervous system disorders
Notes: Ischemic Stroke
Frequency: 6 affected / 172 at risk

Adverse event: Neurologic - TIA
Serious: no
Organ System: Nervous system disorders
Notes: TIA
Frequency: 7 affected / 172 at risk

Adverse event: Pulmonary - Respiratory Failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 172 at risk

Adverse event: Pulmonary - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 172 at risk

Adverse event: Cardiac - Angina/Chest Pain/CAD
Serious: no
Organ System: Cardiac disorders
Notes: Angina/Chest Pain/CAD
Frequency: 5 affected / 172 at risk

Adverse event: Pulmonary - Pleural Effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pleural Effusion (not sanguineous)
Frequency: 4 affected / 172 at risk

Adverse event: COVID-19 Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 172 at risk

Adverse event: Pulmonary - Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 172 at risk

Adverse event: COD Unknown
Serious: no
Organ System: General disorders
Frequency: 6 affected / 172 at risk

Adverse event: Cardiac - Pericardial Effusion (not hemorrhagic)
Serious: no
Organ System: Cardiac disorders
Notes: Pericardial effusion (not hemorrhagic)
Frequency: 4 affected / 172 at risk

Adverse event: Neurologic - Stroke Type Unknown
Serious: no
Organ System: Nervous system disorders
Notes: Stroke Type Unknown
Frequency: 6 affected / 172 at risk

Adverse event: Neurologic - Mental Status Changes/Confusion
Serious: no
Organ System: Nervous system disorders
Notes: Mental Status Changes/Confusion (not stroke or TIA)
Frequency: 3 affected / 172 at risk

Adverse event: Thrombosis - Venous (including DVT)
Serious: no
Organ System: Vascular disorders
Notes: Venous (including DVT)
Frequency: 3 affected / 172 at risk

Adverse event: Renal- AKI (requiring dialysis)
Serious: no
Organ System: Renal and urinary disorders
Notes: AKI (requiring dialysis)
Frequency: 4 affected / 172 at risk

Adverse event: Rehospitalization related to TAVR device or procedure (not listed)
Serious: no
Organ System: General disorders
Notes: Related to TAVR device or procedure (not listed)
Frequency: 4 affected / 172 at risk

Adverse event: Cardiac - Endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 172 at risk

Adverse event: Cardiac - Myocardial Infarction
Serious: no
Organ System: Cardiac disorders
Notes: Myocardial infarction
Frequency: 3 affected / 172 at risk

Adverse event: Thrombosis - Other Systemic (other than stroke)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 172 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 172 at risk

Adverse event: Endocrine Disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 172 at risk

Adverse event: Neurologic - Subdural Hematoma
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 172 at risk

Adverse event: Cardiac - AV Regurg/Leak
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 172 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Vascular disorders
Notes: no intervention required
Frequency: 2 affected / 172 at risk

Adverse event: Septic shock
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 172 at risk

Adverse event: Pulmonary - COPD
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 172 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Vascular disorders
Notes: requires endovascular repair
Frequency: 1 affected / 172 at risk

Adverse event: Vascular AV Fistual
Serious: no
Organ System: Vascular disorders
Notes: intervention required
Frequency: 1 affected / 172 at risk

Adverse event: Neoplasm Benign & Malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Incl Cysts and Polyps
Frequency: 1 affected / 172 at risk

Adverse event: Cardiac - Heart Valve Damage
Serious: no
Organ System: Cardiac disorders
Notes: Heart Valve Damage
Frequency: 1 affected / 172 at risk

Adverse event: Inflammatory/Immunologic
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 172 at risk

Adverse event: Pancreatic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 172 at risk

Adverse event: Cardiac - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 177 at risk

Adverse event: Bleeding - Event Associated with bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Event associated with bleeding
Frequency: 31 affected / 177 at risk

Adverse event: Cardiac - Heart Failure
Serious: yes
Organ System: Cardiac disorders
Notes: Heart Failure
Frequency: 18 affected / 177 at risk

Adverse event: Renal - Other (not bleeding)
Serious: yes
Organ System: Renal and urinary disorders
Notes: Other- not bleeding
Frequency: 8 affected / 177 at risk

Adverse event: Infection - Other (except endocarditis and device infection)
Serious: yes
Organ System: Infections and infestations
Notes: Other (except endocarditis and device infection)
Frequency: 9 affected / 177 at risk

Adverse event: Cardiac - Sudden Cardiac Death/Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Sudden Cardiac Death/Cardiac Arrest
Frequency: 5 affected / 177 at risk

Adverse event: Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 177 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not associated with bleeding
Frequency: 4 affected / 177 at risk

Adverse event: Cancer/Malignancy
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 177 at risk

Adverse event: Pulmonary - Respiratory Failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 177 at risk

Adverse event: Neurologic - Ischemic Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 177 at risk

Adverse event: Pulmonary - Pleural Effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pleural Effusion (not sanguineous)
Frequency: 1 affected / 177 at risk

Adverse event: Neurologic - Other
Serious: yes
Organ System: Nervous system disorders
Notes: Other
Frequency: 3 affected / 177 at risk

Adverse event: Neurologic - Stroke Type Unknown
Serious: yes
Organ System: Nervous system disorders
Notes: Stroke Type Unknown
Frequency: 1 affected / 177 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 177 at risk

Adverse event: Renal - AKI (requiring dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 177 at risk

Adverse event: Cardiac - Pericardial Effusion (not hemorrhagic)
Serious: yes
Organ System: Cardiac disorders
Notes: Pericardial Effusion (not hemorrhagic)
Frequency: 2 affected / 177 at risk

Adverse event: COVID-19 Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 177 at risk

Adverse event: Rehospitalization related to TAVR device or procedure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 177 at risk

Adverse event: Infection - UTI
Serious: yes
Organ System: Infections and infestations
Notes: UTI
Frequency: 2 affected / 177 at risk

Adverse event: Thrombosis - Other systemic
Serious: yes
Organ System: Vascular disorders
Notes: Other systemic (other than stroke)
Frequency: 3 affected / 177 at risk

Adverse event: GI- Other (not bleeding)
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Other (not bleeding)
Frequency: 3 affected / 177 at risk

Adverse event: Cardiac - Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 177 at risk

Adverse event: Pulmonary - Embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Embolism
Frequency: 3 affected / 177 at risk

Adverse event: Neurologic - TIA
Serious: yes
Organ System: Nervous system disorders
Notes: TIA
Frequency: 1 affected / 177 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other
Frequency: 1 affected / 177 at risk

Adverse event: Thrombosis - WATCHMAN Device
Serious: yes
Organ System: Vascular disorders
Notes: WATCHMAN Device
Frequency: 2 affected / 177 at risk

Adverse event: Thrombus- Atrial (not arterial)
Serious: yes
Organ System: Cardiac disorders
Notes: Atrial (not arterial)
Frequency: 2 affected / 177 at risk

Adverse event: Septic shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 177 at risk

Adverse event: Endocrine Disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 177 at risk

Adverse event: Cardiac - Angina/Chest Pain/CAD
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 177 at risk

Adverse event: Neruo- Mental Status Changes/Confusion (not stroke or TIA)
Serious: yes
Organ System: Nervous system disorders
Notes: Mental Status Changes/Confusion (not stroke or TIA)
Frequency: 1 affected / 177 at risk

Adverse event: Thrombosis - Venous (including DVT)
Serious: yes
Organ System: Vascular disorders
Notes: Venous (including DVT)
Frequency: 1 affected / 177 at risk

Adverse event: Thrombosis - TAVR Device
Serious: yes
Organ System: Vascular disorders
Notes: TAVR Device
Frequency: 1 affected / 177 at risk

Adverse event: Thrombosis - Other NON Cardiac Device
Serious: yes
Organ System: Vascular disorders
Notes: Other NON Cardiac Device
Frequency: 1 affected / 177 at risk

Adverse event: Supra-therapeutic INR
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 177 at risk

Adverse event: Hepatobiliary (not bleeding)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 177 at risk

Adverse event: Rehospitalization related to WATCHMAN procedure or device (not listed above)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 177 at risk

Adverse event: Device Embolization - Catheter Retrieval
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 177 at risk

Adverse event: Thrombosis- Venous (including DVT)
Serious: yes
Organ System: Vascular disorders
Notes: Venous (including DVT)
Frequency: 1 affected / 177 at risk

Adverse event: Thrombosis - TAVR Device
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 177 at risk

Adverse event: Rehospitalization related to WATCHMAN procedure or device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 177 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Event Associated with bleeding
Frequency: 57 affected / 177 at risk

Adverse event: Cardiac - Other
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac- Other
Frequency: 57 affected / 177 at risk

Adverse event: Rental
Serious: no
Organ System: Renal and urinary disorders
Notes: Other- not bleeding
Frequency: 8 affected / 177 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 10 affected / 177 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Other (except endocarditis and device infection)
Frequency: 14 affected / 177 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Not associated with bleeding
Frequency: 7 affected / 177 at risk

Adverse event: Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure
Serious: no
Organ System: General disorders
Notes: Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure
Frequency: 12 affected / 177 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Notes: Other
Frequency: 10 affected / 177 at risk

Adverse event: Infection - UTI
Serious: no
Organ System: Renal and urinary disorders
Notes: UTI
Frequency: 5 affected / 177 at risk

Adverse event: Cancer/Malignancy
Serious: no
Organ System: General disorders
Frequency: 9 affected / 177 at risk

Adverse event: Cardiac - Sudden Cardiac Death/Cardiac Arrest
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac - Sudden Cardiac Death/Cardiac Arrest
Frequency: 5 affected / 177 at risk

Adverse event: Neurologic - Ischemic Stroke
Serious: no
Organ System: Nervous system disorders
Notes: Ischemic Stroke
Frequency: 8 affected / 177 at risk

Adverse event: Neurologic - TIA
Serious: no
Organ System: Nervous system disorders
Notes: TIA
Frequency: 4 affected / 177 at risk

Adverse event: Pulmonary - Respiratory Failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 177 at risk

Adverse event: Pulmonary - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 177 at risk

Adverse event: Cardiac - Angina/Chest Pain/CAD
Serious: no
Organ System: Cardiac disorders
Notes: Angina/Chest Pain/CAD
Frequency: 5 affected / 177 at risk

Adverse event: Pulmonary - Pleural Effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pleural Effusion (not sanguineous)
Frequency: 1 affected / 177 at risk

Adverse event: COVID-19 Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 177 at risk

Adverse event: Pulmonary - Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 177 at risk

Adverse event: COD Unknown
Serious: no
Organ System: General disorders
Frequency: 2 affected / 177 at risk

Adverse event: Cardiac - Pericardial Effusion (not hemorrhagic)
Serious: no
Organ System: Cardiac disorders
Notes: Pericardial effusion (not hemorrhagic)
Frequency: 3 affected / 177 at risk

Adverse event: Neurologic - Stroke Type Unknown
Serious: no
Organ System: Nervous system disorders
Notes: Stroke Type Unknown
Frequency: 1 affected / 177 at risk

Adverse event: Neurologic - Mental Status Changes/Confusion
Serious: no
Organ System: Nervous system disorders
Notes: Mental Status Changes/Confusion (not stroke or TIA)
Frequency: 4 affected / 177 at risk

Adverse event: Thrombosis - Venous (including DVT)
Serious: no
Organ System: Vascular disorders
Notes: Venous (including DVT)
Frequency: 3 affected / 177 at risk

Adverse event: Renal- AKI (requiring dialysis)
Serious: no
Organ System: Renal and urinary disorders
Notes: AKI (requiring dialysis)
Frequency: 2 affected / 177 at risk

Adverse event: Rehospitalization related to TAVR device or procedure (not listed)
Serious: no
Organ System: General disorders
Notes: Related to TAVR device or procedure (not listed)
Frequency: 2 affected / 177 at risk

Adverse event: Thrombus - Atrial (not arterial)
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 177 at risk

Adverse event: Cardiac - Endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 177 at risk

Adverse event: GI- Other (not bleeding)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 177 at risk

Adverse event: Cardiac - Myocardial Infarction
Serious: no
Organ System: Cardiac disorders
Notes: Myocardial infarction
Frequency: 1 affected / 177 at risk

Adverse event: Thrombosis - Other Systemic (other than stroke)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 177 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 177 at risk

Adverse event: Endocrine Disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 177 at risk

Adverse event: Pulmonary - Embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 177 at risk

Adverse event: Thrombosis - WATCHMAN Device
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 177 at risk

Adverse event: Septic shock
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 177 at risk

Adverse event: Cardiac - Atrial Septal Defect (latrogenic)
Serious: no
Organ System: Cardiac disorders
Notes: Atrial Septal Defect (latrogenic)
Frequency: 2 affected / 177 at risk

Adverse event: Device Embolization - Catheter Retrieval
Serious: no
Organ System: Vascular disorders
Notes: Catheter Retrieval
Frequency: 2 affected / 177 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 177 at risk

Adverse event: Thrombosis - TAVR Device
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 177 at risk

Adverse event: Vascular AV Fistula
Serious: no
Organ System: Vascular disorders
Notes: no intervention required
Frequency: 1 affected / 177 at risk

Adverse event: Thrombosis - Other NON Cardiac Device
Serious: no
Organ System: Vascular disorders
Notes: Other NON Cardiac Device
Frequency: 1 affected / 177 at risk

Adverse event: Thrombosis - Other Cardiac Device
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 177 at risk

Adverse event: Supra-therapeutic INR
Serious: no
Organ System: General disorders
Frequency: 1 affected / 177 at risk

Adverse event: Hepatobiliary (not bleeding)
Serious: no
Organ System: Hepatobiliary disorders
Notes: not bleeding
Frequency: 1 affected / 177 at risk

Adverse event: Rehospitalization related to WATCHMAN procedure or device
Serious: no
Organ System: General disorders
Notes: Related to WATCHMAN procedure or device
Frequency: 1 affected / 177 at risk