Study: NCT00739401

Adverse event: Blood and Lymphatic Disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Cardiac Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 44 at risk

Adverse event: Gastrointestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 44 at risk

Adverse event: Implant-Related Events
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 44 at risk

Adverse event: Musculoskeletal Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Neoplasms
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: Other- SFA Rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Respiratory Disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Supplemental Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 44 at risk

Adverse event: Vascular Disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 44 at risk

Adverse event: Blood and Lymphatic System Disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 44 at risk

Adverse event: Cardiac Disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Endocrine disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 44 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Frequency: 6 affected / 44 at risk

Adverse event: Infections and Infestations
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 44 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Neoplasms benign, malignant and unspecified (inc cysts and polyps)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: Product issues
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 44 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 44 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Surgical and medical procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 44 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 44 at risk