Study: NCT03124875

Adverse event: Access Site Bleeding Requiring Transfusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 32 at risk

Adverse event: Oedema
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Ischemia, Target Limb (Failed Procedure)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Non-Study Device Balloon Rupture and Embolization Requiring Additional Treatment/Stenting
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 32 at risk

Adverse event: Vessel Occlusion/Thrombus Formation
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 32 at risk

Adverse event: Wound Bleeding or Requiring Debridement
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Wound Infection, New or Worsening
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 32 at risk

Adverse event: Access Site Pain or Oozing
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 32 at risk

Adverse event: Cardiac failure acute
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 32 at risk

Adverse event: Deterioration in Renal Function
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 32 at risk

Adverse event: HyperGlyemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Immediate Post Procedure Edema
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 32 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 32 at risk

Adverse event: New Wound on Target Limb
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pain, Target Limg
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Post-Procedure Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Rectal prolapse
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Vessel Occlusion/Thrombus Formation
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vessel Perforation Requiring Treatment (investigational device-related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 32 at risk

Adverse event: Vessel Stenosis Requiring Reintervention
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 32 at risk

Adverse event: Wound Bleeding or Requiring Debridement
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 32 at risk

Adverse event: Wound Infection, New or Worsening
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 32 at risk