Study: NCT02000115

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 381 at risk

Adverse event: Aortic- Aortic Dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 381 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 38 affected / 381 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 381 at risk

Adverse event: EKG Abnormalities
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 381 at risk

Adverse event: Echo finding
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 381 at risk

Adverse event: Endocarditis- Infective/Bacterial Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 381 at risk

Adverse event: General- Asystole
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 381 at risk

Adverse event: General-Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 381 at risk

Adverse event: General- Cardiac Perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 381 at risk

Adverse event: General-Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 381 at risk

Adverse event: General- Coronary Artery Disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 381 at risk

Adverse event: General-Coronary Artery Occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 381 at risk

Adverse event: General-Hypervolemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 381 at risk

Adverse event: General- Pericardial Effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 381 at risk

Adverse event: General- Pericardial Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 381 at risk

Adverse event: General-Pulmonary Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 381 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 98 affected / 381 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 56 affected / 381 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 381 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 381 at risk

Adverse event: Shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 381 at risk

Adverse event: Valve- Aortic Valve Regurgitation/Aortic Valve Insufficiency/Valvular Regurgitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 381 at risk

Adverse event: Valve- Aortic Valve Stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 381 at risk

Adverse event: Valve- Mitral Valve Regurgitation/Mitral Insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 381 at risk

Adverse event: Valve- Mitral Valve Stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 381 at risk

Adverse event: Valve- Perivalvular Leak
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 381 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 381 at risk

Adverse event: General-Dematological
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 381 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 381 at risk

Adverse event: Nose and Paranasal Sinuses
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 381 at risk

Adverse event: Disorders of Carbohydrate Metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 381 at risk

Adverse event: General- Fluid, Electrolyte, Endocine and Metabolic Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 381 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 381 at risk

Adverse event: Esophageal Laceration and Rupture
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: General-Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 381 at risk

Adverse event: General-Gastrointestinal Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 381 at risk

Adverse event: Hepatic and Biliary Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 381 at risk

Adverse event: General-Genitourinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 21 affected / 381 at risk

Adverse event: General-Genitourinary Symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 381 at risk

Adverse event: Prostate Disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 381 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 381 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 381 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 381 at risk

Adverse event: Anemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 36 affected / 381 at risk

Adverse event: General-Hematology and Oncology
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 43 affected / 381 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 381 at risk

Adverse event: General- Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 381 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 381 at risk

Adverse event: Miscellaneous- Device Malposition or Malfunction
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 381 at risk

Adverse event: Miscellaneous- Device Migration
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 381 at risk

Adverse event: Miscellaneous-Thrombus on Device
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 381 at risk

Adverse event: Miscellaneous- General
Serious: yes
Organ System: General disorders
Frequency: 60 affected / 381 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 381 at risk

Adverse event: General-Musculoskeletal and Connective Tissue Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 381 at risk

Adverse event: General- Musculoskeletal Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 381 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 381 at risk

Adverse event: General-Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 33 affected / 381 at risk

Adverse event: General- Neurological Symptoms
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 381 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 381 at risk

Adverse event: Neurological Hematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 381 at risk

Adverse event: Seizure/Convulsions/Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 381 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 381 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 381 at risk

Adverse event: Chronic Obstructive Airway Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 381 at risk

Adverse event: General- Pulmonary/Respiratory Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 381 at risk

Adverse event: Eosinophilic Pneumonias
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 381 at risk

Adverse event: Pleural Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 381 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 381 at risk

Adverse event: VASC Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 381 at risk

Adverse event: VASC Hematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 381 at risk

Adverse event: VASC Pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 381 at risk

Adverse event: VASC Vascular Rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 381 at risk

Adverse event: VASC Vessel Dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 381 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 381 at risk

Adverse event: Aortic-Aortic Dissection
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 381 at risk

Adverse event: Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 54 affected / 381 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 381 at risk

Adverse event: EKG Abnormalities
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 381 at risk

Adverse event: Echo Finding
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 381 at risk

Adverse event: General
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 381 at risk

Adverse event: General- Cardiovascular Symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 381 at risk

Adverse event: Atrioventricular block
Serious: no
Organ System: Cardiac disorders
Frequency: 102 affected / 381 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 381 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 381 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 381 at risk

Adverse event: Valve-Aortic Valve Regurgitation/Aortic Valve Insufficiency/Valvular Regurgitation Aortic Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 381 at risk

Adverse event: Valve- Mitral Valve Regurgitation/Mitral Insufficiency
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 381 at risk

Adverse event: Valve- Perivalvular Leak
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 381 at risk

Adverse event: Valve-Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation Tricuspid Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 381 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 381 at risk

Adverse event: General-Dermatogical
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 381 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 381 at risk

Adverse event: Dental Disorders
Serious: no
Organ System: General disorders
Frequency: 3 affected / 381 at risk

Adverse event: Nose and Paranasal Sinuses
Serious: no
Organ System: General disorders
Frequency: 7 affected / 381 at risk

Adverse event: Throat
Serious: no
Organ System: General disorders
Frequency: 1 affected / 381 at risk

Adverse event: Disorders of Carbohydrate Metabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 381 at risk

Adverse event: General- Fluid, Electrolyte, Endocrine and Metabolic Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 381 at risk

Adverse event: Thyroid Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 381 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: General
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 381 at risk

Adverse event: General- Gastrointestinal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 381 at risk

Adverse event: Hepatic and Biliary Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 381 at risk

Adverse event: General- Genitourinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 35 affected / 381 at risk

Adverse event: General- Genitourinary Symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 381 at risk

Adverse event: Myoneurogenic Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 381 at risk

Adverse event: Prostate Disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 381 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 381 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Renal and urinary disorders
Frequency: 33 affected / 381 at risk

Adverse event: Anemias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 46 affected / 381 at risk

Adverse event: General- Hematology and Oncology
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 87 affected / 381 at risk

Adverse event: General- Infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 381 at risk

Adverse event: Viral
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 381 at risk

Adverse event: Device Malposition or Malfunction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 381 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 381 at risk

Adverse event: Thrombus on Device
Serious: no
Organ System: Product Issues
Frequency: 11 affected / 381 at risk

Adverse event: General-Miscellaneous
Serious: no
Organ System: General disorders
Frequency: 87 affected / 381 at risk

Adverse event: Achilles Tendon Tear
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 381 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 381 at risk

Adverse event: General
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 381 at risk

Adverse event: General- Musculoskeletal Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 381 at risk

Adverse event: General-Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 381 at risk

Adverse event: General- Neurological Symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 381 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 381 at risk

Adverse event: General- Opthalmologic Disorders
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 381 at risk

Adverse event: General- Opthalmic Symptoms
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 381 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 381 at risk

Adverse event: Chronic Obstructive Airway Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 381 at risk

Adverse event: General- Pulmonary/Respiratory Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 381 at risk

Adverse event: Pleural Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 381 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 381 at risk

Adverse event: X-ray Finding
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 381 at risk

Adverse event: VASC Bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 381 at risk

Adverse event: VASC Hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 381 at risk

Adverse event: VASC Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 381 at risk

Adverse event: VASC Pseudoaneurysm
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 381 at risk

Adverse event: VASC Vessel Dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 381 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 369 at risk

Adverse event: Aorta- Aortic Calcification
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 369 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 369 at risk

Adverse event: EKG Abnormalities
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 369 at risk

Adverse event: Echo finding
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: Endocarditis- Prosthetic Valvular Endocarditis (PVE)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: General-Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 369 at risk

Adverse event: General- Cardiac Perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: General-Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: General-Coronary Artery Occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 369 at risk

Adverse event: General-Hypertensive Crisis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 369 at risk

Adverse event: General-Hypervolemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 369 at risk

Adverse event: General- Myocardial Ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: General- Pericardial Effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 369 at risk

Adverse event: General- Pericardial Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 369 at risk

Adverse event: General-Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: General-Pulmonary Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: General- Cardiovascular Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 37 affected / 369 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 39 affected / 369 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 369 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 369 at risk

Adverse event: Shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 369 at risk

Adverse event: Valve- Aortic Valve Regurgitation/Aortic Valve Insufficiency/Valvular Regurgitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: Valve- Aortic Valve Stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: Valve- Mitral Valve Regurgitation/Mitral Insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: Valve- Mitral Valve Stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: Valve- Perivalvular Leak
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 369 at risk

Adverse event: Valve- Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation Tricuspid Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 369 at risk

Adverse event: General-Dematological
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 369 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 369 at risk

Adverse event: Nose and Paranasal Sinuses
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 369 at risk

Adverse event: Throat- Cough
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 369 at risk

Adverse event: Disorders of Carbohydrate Metabolism
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 369 at risk

Adverse event: General- Fluid, Electrolyte, Endocine and Metabolic Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 369 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 369 at risk

Adverse event: General-Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 369 at risk

Adverse event: General-Gastrointestinal Symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 369 at risk

Adverse event: Hepatic and Biliary Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 369 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 369 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 369 at risk

Adverse event: General-Genitourinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 17 affected / 369 at risk

Adverse event: General-Genitourinary Symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 369 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 369 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 14 affected / 369 at risk

Adverse event: Endometriosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 369 at risk

Adverse event: Anemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 369 at risk

Adverse event: General-Hematology and Oncology
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 369 at risk

Adverse event: General- Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 369 at risk

Adverse event: Miscellaneous- Device Malposition or Malfunction
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 369 at risk

Adverse event: Miscellaneous-Thrombus on Device
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 369 at risk

Adverse event: Miscellaneous- General
Serious: yes
Organ System: General disorders
Frequency: 60 affected / 369 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 369 at risk

Adverse event: General-Musculoskeletal and Connective Tissue Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 369 at risk

Adverse event: General- Musculoskeletal Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 369 at risk

Adverse event: General-Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 18 affected / 369 at risk

Adverse event: General- Neurological Symptoms
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 369 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 369 at risk

Adverse event: Neurological Hematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 369 at risk

Adverse event: Seizure/Convulsions/Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 369 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 18 affected / 369 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 369 at risk

Adverse event: Chronic Obstructive Airway Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 369 at risk

Adverse event: General- Pulmonary/Respiratory Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 369 at risk

Adverse event: Idiopathic Interstitial Lung Diseases
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 369 at risk

Adverse event: Pleural Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 369 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 369 at risk

Adverse event: VASC Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 369 at risk

Adverse event: VASC Hematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 369 at risk

Adverse event: VASC Pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 369 at risk

Adverse event: VASC Vascular Rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 369 at risk

Adverse event: VASC Vessel Perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 369 at risk

Adverse event: VASC Vessel Stenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 369 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 369 at risk

Adverse event: Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 45 affected / 369 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 369 at risk

Adverse event: EKG Abnormalities
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 369 at risk

Adverse event: Echo Finding
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 369 at risk

Adverse event: General
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 369 at risk

Adverse event: General- Cardiovascular Symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 369 at risk

Adverse event: Atrioventricular block
Serious: no
Organ System: Cardiac disorders
Frequency: 83 affected / 369 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 369 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 369 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: Valve-Aortic Valve Regurgitation/Aortic Valve Insufficiency/Valvular Regurgitation Aortic Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 369 at risk

Adverse event: Valve- Aortic Valve Stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 369 at risk

Adverse event: Valve- Mitral Valve Regurgitation/Mitral Insufficiency
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 369 at risk

Adverse event: Valve- Perivalvular Leak
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 369 at risk

Adverse event: Valve-Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation Tricuspid Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: Cardiomegaly
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 369 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 369 at risk

Adverse event: General-Dermatogical
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 369 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 369 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 369 at risk

Adverse event: Dental Disorders
Serious: no
Organ System: General disorders
Frequency: 2 affected / 369 at risk

Adverse event: Nose and Paranasal Sinuses
Serious: no
Organ System: General disorders
Frequency: 2 affected / 369 at risk

Adverse event: Throat
Serious: no
Organ System: General disorders
Frequency: 3 affected / 369 at risk

Adverse event: Disorders of Carbohydrate Metabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 369 at risk

Adverse event: General- Fluid, Electrolyte, Endocrine and Metabolic Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 369 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 369 at risk

Adverse event: Esophageal Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 369 at risk

Adverse event: General
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 369 at risk

Adverse event: General- Gastrointestinal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 369 at risk

Adverse event: Hepatic and Biliary Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 369 at risk

Adverse event: General- Genitourinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 41 affected / 369 at risk

Adverse event: General- Genitourinary Symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 369 at risk

Adverse event: Prostate Disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 369 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 369 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Renal and urinary disorders
Frequency: 20 affected / 369 at risk

Adverse event: Anemias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 369 at risk

Adverse event: General- Hematology and Oncology
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 56 affected / 369 at risk

Adverse event: Fungal Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 369 at risk

Adverse event: General- Infections
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 369 at risk

Adverse event: Viral
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 369 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 369 at risk

Adverse event: Device Malposition or Malfunction
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 369 at risk

Adverse event: Thrombus on Device
Serious: no
Organ System: Product Issues
Frequency: 11 affected / 369 at risk

Adverse event: General-Miscellaneous
Serious: no
Organ System: General disorders
Frequency: 68 affected / 369 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 369 at risk

Adverse event: General
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 369 at risk

Adverse event: General- Musculoskeletal Symptoms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 369 at risk

Adverse event: General-Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 369 at risk

Adverse event: General- Neurological Symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 369 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 369 at risk

Adverse event: Subdural haematoma
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 369 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 369 at risk

Adverse event: General- Opthalmic Symptoms
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 369 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 369 at risk

Adverse event: Chronic Obstructive Airway Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 369 at risk

Adverse event: General- Pulmonary/Respiratory Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 369 at risk

Adverse event: Idiopathic Interstitial Lung Diseases
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 369 at risk

Adverse event: Pleural Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 369 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 369 at risk

Adverse event: VASC Bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 369 at risk

Adverse event: VASC Irreversible Nerve Damage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 369 at risk

Adverse event: VASC Vessel Dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 369 at risk

Adverse event: VASC Vessel Stenosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 369 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 100 at risk

Adverse event: General- Coronary Artery Disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: General- Pericardial Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 100 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 100 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 100 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 100 at risk

Adverse event: Valve- Aortic Valve Regurgitation/Aortic Valve Insufficiency/Valvular Regurgitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: General- Fluid, Electrolyte, Endocine and Metabolic Disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 100 at risk

Adverse event: General-Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Hepatic and Biliary Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: General-Genitourinary Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 100 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 100 at risk

Adverse event: Anemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 100 at risk

Adverse event: General-Hematology and Oncology
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 100 at risk

Adverse event: General- Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: Miscellaneous- Device Migration
Serious: yes
Organ System: Product Issues
Frequency: 2 affected / 100 at risk

Adverse event: Miscellaneous- General
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 100 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: General-Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 100 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Chronic Obstructive Airway Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: General- Pulmonary/Respiratory Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Pleural Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: VASC Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 100 at risk

Adverse event: VASC Pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 100 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 100 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: General
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 100 at risk

Adverse event: Atrioventricular block
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 100 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Valve-Aortic Valve Regurgitation/Aortic Valve Insufficiency/Valvular Regurgitation Aortic Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 100 at risk

Adverse event: Valve- Perivalvular Leak
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 100 at risk

Adverse event: General-Dermatogical
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: General- Fluid, Electrolyte, Endocrine and Metabolic Disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 100 at risk

Adverse event: General- Genitourinary Disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 100 at risk

Adverse event: Urinary Tract Infections
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 100 at risk

Adverse event: Anemias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 100 at risk

Adverse event: General- Hematology and Oncology
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 100 at risk

Adverse event: Thrombus on Device
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 100 at risk

Adverse event: General-Miscellaneous
Serious: no
Organ System: General disorders
Frequency: 9 affected / 100 at risk

Adverse event: General-Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: General- Neurological Symptoms
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 100 at risk

Adverse event: General- Pulmonary/Respiratory Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Pleural Disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: VASC Bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 100 at risk

Adverse event: VASC Hematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk