Study: NCT02921230

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 32 affected / 492 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 32 affected / 492 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 492 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 492 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 492 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 492 at risk

Adverse event: Peripheral embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 492 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Arterial disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Extremity necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Reperfusion injury
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Vascular dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: General disorders
Frequency: 21 affected / 492 at risk

Adverse event: Vascular stent thrombosis
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 492 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 492 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 492 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 492 at risk

Adverse event: Necrosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 492 at risk

Adverse event: Stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 492 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 492 at risk

Adverse event: Reocclusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 492 at risk

Adverse event: Peripheral artery restenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 492 at risk

Adverse event: Vascular graft occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 492 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 492 at risk

Adverse event: Vascular access site pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 492 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Product Issues
Frequency: 20 affected / 492 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 492 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Post procedural sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 492 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 492 at risk

Adverse event: Gastrointestinal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 492 at risk

Adverse event: Small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 492 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 492 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 492 at risk

Adverse event: Retroperitoneal haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 492 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 492 at risk

Adverse event: Compartment syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 492 at risk

Adverse event: Dermatitis allergic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 492 at risk

Adverse event: Arterial haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Venous stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Vascular stent occlusion
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 492 at risk

Adverse event: Peripheral arterial reocclusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 492 at risk

Adverse event: Coronavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 492 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 492 at risk

Adverse event: Lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 492 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 492 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 492 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 492 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 492 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Idiopathic interstitial pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 492 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 492 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 492 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 492 at risk

Adverse event: Peripheral artery stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 492 at risk

Adverse event: Peripheral artery occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 492 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 492 at risk

Adverse event: Vascular dissection
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 492 at risk

Adverse event: Femoral artery dissection
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 492 at risk

Adverse event: Artery dissection
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 492 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 492 at risk

Adverse event: Aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Arterial spasm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 492 at risk

Adverse event: Peripheral embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Vascular occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 492 at risk

Adverse event: Vascular stent stenosis
Serious: no
Organ System: General disorders
Frequency: 9 affected / 492 at risk

Adverse event: Vascular stent stenosis
Serious: no
Organ System: General disorders
Frequency: 5 affected / 492 at risk

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 4 affected / 492 at risk

Adverse event: Vascular stent thrombosis
Serious: no
Organ System: General disorders
Frequency: 5 affected / 492 at risk

Adverse event: Stenosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 492 at risk

Adverse event: Puncture site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 492 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 492 at risk

Adverse event: Puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 492 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 492 at risk

Adverse event: Subcutaneous haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 492 at risk

Adverse event: Peripheral artery restenosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 492 at risk

Adverse event: Vascular procedure complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 492 at risk

Adverse event: Post procedural haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 492 at risk

Adverse event: Postoperative thrombosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 492 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 492 at risk

Adverse event: Reocclusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 492 at risk

Adverse event: Urinary retention postoperative
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 492 at risk

Adverse event: Device occlusion
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 492 at risk

Adverse event: Diabetic foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 492 at risk

Adverse event: Skin maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 492 at risk

Adverse event: Contrast media allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 492 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 7 affected / 492 at risk

Adverse event: Vascular stent occlusion
Serious: no
Organ System: General disorders
Frequency: 7 affected / 492 at risk

Adverse event: Peripheral arterial reocclusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 492 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 273 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 273 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 273 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 273 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 273 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 273 at risk

Adverse event: Femoral artery dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 273 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 273 at risk

Adverse event: Vascular stent thrombosis
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 273 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 273 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 273 at risk

Adverse event: Stenosis
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 273 at risk

Adverse event: Device embolisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 273 at risk

Adverse event: Puncture site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 273 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 273 at risk

Adverse event: Reocclusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 273 at risk

Adverse event: Peripheral artery restenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 273 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 273 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Product Issues
Frequency: 6 affected / 273 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 273 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 273 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 273 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 273 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 273 at risk

Adverse event: Arterial stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 273 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 273 at risk

Adverse event: Vascular stent occlusion
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 273 at risk

Adverse event: Catheter site inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 273 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 273 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 273 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 273 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 273 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 273 at risk

Adverse event: Breast cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 273 at risk

Adverse event: Bronchial carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 273 at risk

Adverse event: Malignant peritoneal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 273 at risk

Adverse event: Ovarian cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 273 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 273 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 273 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 273 at risk

Adverse event: Peripheral artery stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 273 at risk

Adverse event: Peripheral artery occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 273 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 273 at risk

Adverse event: Femoral artery dissection
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 273 at risk

Adverse event: Artery dissection
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 273 at risk

Adverse event: Arteriovenus fistula
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 273 at risk

Adverse event: Vascular stent stenosis
Serious: no
Organ System: General disorders
Frequency: 12 affected / 273 at risk

Adverse event: Vascular stent stenosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 273 at risk

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 273 at risk

Adverse event: Vascular stent thrombosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 273 at risk

Adverse event: Stenosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 273 at risk

Adverse event: Puncture site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 273 at risk

Adverse event: Device embolisation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 273 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 273 at risk

Adverse event: Peripheral artery restenosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 273 at risk

Adverse event: Vascular procedure complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 273 at risk

Adverse event: Arterial restenosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 273 at risk

Adverse event: Device occlusion
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 273 at risk

Adverse event: Contrast media reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 273 at risk