Study: NCT01074658

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 996 at risk

Adverse event: Vessel dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 996 at risk

Adverse event: Access site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 996 at risk

Adverse event: Access vessel dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 996 at risk

Adverse event: Access vessel perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 996 at risk

Adverse event: Acute vessel occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 996 at risk

Adverse event: Hemorrhage requiring transfusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 996 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 996 at risk

Adverse event: Reposition with snare
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 996 at risk

Adverse event: Valve in valve
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 996 at risk

Adverse event: Valve retrieval
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 996 at risk

Adverse event: Valve dislocation into LVOT
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 996 at risk

Adverse event: Valve dislocation into annular aorta
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 996 at risk

Adverse event: Ventricular rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 996 at risk

Adverse event: Hemodynamic instability requiring Heart/Lung machine
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 996 at risk

Adverse event: Resuscitation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 996 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 996 at risk

Adverse event: Failure of closure device requiring surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 11 affected / 996 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 996 at risk

Adverse event: Other Procedural Complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 996 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 45 affected / 996 at risk

Adverse event: Stroke/TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 30 affected / 996 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Myocardial infarction was defined according to the definition proposed by the The Joint ESC/ACC/AHA/WHF Task Force and Academic Research Consortium.(Thygesen K, Alpert JS, White HD. Circulation. 2007;116:2634-2653)
Frequency: 110 affected / 996 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 35 affected / 996 at risk

Adverse event: Prosthetic cardiac valve malfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 996 at risk

Adverse event: Nonstructural Valve Dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 996 at risk

Adverse event: Bleeding Event
Serious: yes
Organ System: Vascular disorders
Notes: Any episode of major internal or external bleeding that causes death, hospitalization, or permanent injury (i.e. vision loss) or necessitates transfusion.
Frequency: 87 affected / 996 at risk

Adverse event: Permanent Pacemaker Implantation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 209 affected / 996 at risk

Adverse event: Other Serious Adverse Event
Serious: yes
Organ System: General disorders
Frequency: 213 affected / 996 at risk

Adverse event: AE related to Device
Serious: no
Organ System: General disorders
Frequency: 84 affected / 996 at risk

Adverse event: AE related to Index procedure
Serious: no
Organ System: General disorders
Frequency: 535 affected / 996 at risk