Table 1

Acute studies

Pig number	Complications
Pig 1	Kinking of the loops in the LV. Haematoma in the annulus of the mitral valve. Device position too low, ie, located in the IVC
Pig 2	Kinking of the loop. Device caught by Eustachian valve
Pig 3	Pericardial effusion during puncture of the atrial septum. Kinking of the loop. Damage to aortic valve
Pig 4	Died from ventricular fibrillation
Pig 5	Separation of the two umbrellas a few seconds after implantation. Retraction of the right atrial umbrella. Embolisation of the left atrial umbrella to the aortic valve. Corresponding to a weld on the metallic skeleton, a fracture of one arm in this umbrella had occurred. This was the only pig in which we intended to implant a 45 mm oversized device
Pig 6	Pre-existing ASD. Too big for closure with a 35 mm device. Successful retrieval of the device was performed
Pig 7	Pre-existing ASD. Too big for closure with a 35 mm device. Successful retrieval of the device was performed
Pig 8	Laceration of the inguinal ligament and the femoral artery
Pig 9	Laceration of the inguinal ligament and the femoral artery