Study: NCT02556255

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: 329 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: 144 \& 356 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 2 affected / 46 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Notes: 82 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Non STEMI@Atrioventricular block@Cardiogenic shock@Acute renal failure
Serious: yes
Organ System: Cardiac disorders
Notes: 322 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 8 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Gastrointestinal angiodysplasia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 126 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Upper gastrointestinal hemorrhage@ Esophagitis@ Gastroesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 92 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Vascular access site haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: 0 days post procedure. Not related to the Investigational Device. Causal relationship to the index procedure.
Frequency: 2 affected / 46 at risk

Adverse event: Superficial femoral arterial stenosis & Claudication@Leg ischemia@Disease progression
Serious: yes
Organ System: Vascular disorders
Notes: 8 \& 197 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 2 affected / 46 at risk

Adverse event: Leg ischemia@Superficial femoral arterial stenosis@Claudication
Serious: yes
Organ System: Vascular disorders
Notes: 384 days post procedure. Not related to the Investigational Device. Possibly related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Non STEMI@ Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: 319 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Notes: 308 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: 319 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Leg ischemia@ Popliteal arterial restenosis
Serious: yes
Organ System: Vascular disorders
Notes: 245 days post procedure. Might be related to both device or Index procedure and judged to be more due to Index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: 232 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Vascular dissection
Serious: no
Organ System: Vascular disorders
Notes: 0 days post procedure. Not related to the Investigational Device. Definitely related to the index procedure. Minor dissection.
Frequency: 3 affected / 46 at risk

Adverse event: Arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Notes: 163 days post procedure. Not related to the Investigational Device. Related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 0 days post procedure. Not related to the Investigational Device. Definitely related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Leg ischemia@Superficial femoral arterial stenosis
Serious: no
Organ System: Vascular disorders
Notes: 195 \& 207 \& 221 \& 324 days post procedures. Not related to the Investigational Device. Probably not related to the index procedure.
Frequency: 4 affected / 46 at risk

Adverse event: Peripheral ischaemia
Serious: no
Organ System: Vascular disorders
Notes: 188 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Vascular disorders
Notes: 31 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 20 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: 287 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: 180 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 1 affected / 46 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: 4 \& 28 days post procedure. Not related to the Investigational Device. Not related to the index procedure.
Frequency: 2 affected / 46 at risk