Study: NCT00805948

Adverse event: Aortic valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 154 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 154 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 154 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 154 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 154 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 154 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Stent-graft endoleak
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 154 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Groin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Infective aneurysm
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 154 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 154 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 154 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 154 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 154 at risk

Adverse event: Compartment syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Metastases to bone
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 154 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 154 at risk

Adverse event: Paraparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 154 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 154 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 154 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 154 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 154 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 154 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 154 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 154 at risk

Adverse event: Diaphragmatic paralysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 154 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 154 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 154 at risk

Adverse event: Aneurysm ruptured
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 154 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 154 at risk

Adverse event: Aortic aneurysm rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 154 at risk

Adverse event: Aortic dilatation
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 154 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 154 at risk

Adverse event: Aortic rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 154 at risk

Adverse event: Arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 154 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 154 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 154 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 154 at risk

Adverse event: Peripheral artery dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 154 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 154 at risk

Adverse event: Pulmonary complications (general)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 61 affected / 195 at risk

Adverse event: Renal complications (general)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 17 affected / 195 at risk

Adverse event: Cardiac and hemodynamic (general)
Serious: yes
Organ System: Cardiac disorders
Frequency: 50 affected / 195 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 195 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 195 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 195 at risk

Adverse event: Neurologic (general)
Serious: yes
Organ System: Nervous system disorders
Frequency: 20 affected / 195 at risk

Adverse event: Paraplegia and paraparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 195 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 14 affected / 195 at risk

Adverse event: Transient Ischemic Attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 195 at risk

Adverse event: Gastrointestinal (general)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 195 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 195 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 195 at risk

Adverse event: Bleeding and hematogenic
Serious: yes
Organ System: Vascular disorders
Frequency: 69 affected / 195 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 195 at risk

Adverse event: Arterial
Serious: yes
Organ System: Vascular disorders
Frequency: 50 affected / 195 at risk

Adverse event: Arterial embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 195 at risk

Adverse event: Arterial insertion trauma
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 195 at risk

Adverse event: TAA rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 195 at risk

Adverse event: Venous
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 195 at risk

Adverse event: Graft endoleak
Serious: yes
Organ System: General disorders
Frequency: 29 affected / 195 at risk

Adverse event: Graft migration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 195 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 18 affected / 195 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 195 at risk

Adverse event: Urologic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 195 at risk

Adverse event: Other-Enlarged Lymph Nodes - Right
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - (L) Hip Dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - (L) Knee Replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 195 at risk

Adverse event: Other - (R) Hip Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 195 at risk

Adverse event: Other - Acute Morphine Poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 195 at risk

Adverse event: Other - Arthritis of Knee
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Auditory and Visual
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Broken Hip
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Cervical Spine Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 195 at risk

Adverse event: Other - Cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Degenerative Joint Disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Fall - FX Hip
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 195 at risk

Adverse event: Other - Fracture of Left Leg
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 195 at risk

Adverse event: Other - Fractured Left Foot
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 195 at risk

Adverse event: Other - Hernia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 195 at risk

Adverse event: Other - Hip Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 195 at risk

Adverse event: Other - Hypercalcemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Hypoalbuminemia/Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Immature Fistula, Permacath
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 195 at risk

Adverse event: Other - Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 195 at risk

Adverse event: Other - Osteoarthritis (L) Knee
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Osteoarthritis/(L) Total Knee
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Right Femur Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 195 at risk

Adverse event: Other - Splenic Rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 195 at risk

Adverse event: Other - Suicidal Ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Uterine Prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 195 at risk

Adverse event: Other - Back Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 195 at risk

Adverse event: Other - Fever
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 195 at risk

Adverse event: Other - Fever
Serious: yes
Organ System: Infections and infestations
Notes: Fungemia
Frequency: 1 affected / 195 at risk

Adverse event: Other - Pain
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 195 at risk

Adverse event: Other - Pain
Serious: yes
Organ System: General disorders
Notes: Right groin
Frequency: 1 affected / 195 at risk

Adverse event: Other - Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Left side of neck, left arm and leg
Frequency: 1 affected / 195 at risk

Adverse event: Other - Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: (L) calf pain
Frequency: 1 affected / 195 at risk