Possibility of a tear on the left atrial wall during use of the device.
Infants at highest risk for injury. Sudden obstruction of trachea could lead to respiratory arrest/death. In all patient populations, failure may result in need for surgical intervention to replace failed device.
Damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage.
Post-operative fracture of the pin that connects the head to the plate body.