Conversion to open sternotomy during the TAVI procedure secondary to any procedure-related complications

 Unplanned use of CPB for haemodynamic support at any time during the TAVI procedure

 Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure

 Angiographic or echocardiographic evidence of a new septal perforation during or after the TAVI procedure

 Angiographic or echocardiographic evidence of new damage (chordae papillary muscle, or to the leaflet) to the mitral valve apparatus or dysfunction (e.g. restrictions due to the THV) of the mitral valve during or after the TAVI procedure

 Evidence of a new pericardial effusion associated with haemodynamic instability and clearly related to the TAVI procedure

 Any one of the following

 Fulfilment of the Duke endocarditis criteria^a

 Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriological studies during a re-operation

 Findings of abscess, pus, or vegetation involving a repaired or replaced valve during an autopsy

 Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. Note that valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve-related should not be reported as valve thrombosis

 Valve migration

•  After initial correct positioning, the valve prosthesis moves upwards or downwards, within the aortic annulus from its initial position, with or without consequences

 Valve embolization

•  The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus

 Ectopic valve deployment

•  Permanent deployment of the valve prosthesis in a location other than the aortic root

 An additional valve prosthesis is implanted within a previously implanted prosthesis because of suboptimal device position and/or function, during or after the index procedure