8
5. Gently pull on the Handle to bring the left atrial disc onto the surface of the
left atrial septum.
6. Deploy the right atrial disc by pushing the Slider to the left until it stops
and then down. Confirm that the Slider has moved completely to the left
and down position (Figure 6c). Failure to move the Slider completely to the
left and down position may prevent Occluder locking.
7. Confirm that both left and right discs appear planar and apposed to the
septum with septal tissue between the discs.
If the position is not correct, refer to Section G, “Reloading the
Occluder”. Note that the Occluder can only be Reloaded prior to
Occluder Locking.
FIGURE 6: Occluder Deployment
FIGURE 6a: Initial Occluder Deployment
FIGURE 6b: Left Atrial Disc Deployment
FIGURE 6c: Right Atrial Disc Deployment
F. Occluder Locking and Delivery System Removal
1. Prior to Occluder locking, assess that the Occluder position and defect
closure are acceptable and that the Delivery System is not exerting tension
on the septum and Occluder.
2. Lock the Occluder by holding the Handle in a fixed position to prevent
applying tension on the Occluder. Note that excessive compression of
the handle may prevent Occluder locking. Next, squeeze and then slide
the Occluder Lock decisively and with a consistent amount of force to the
right (Figure 7). At the completion of Occluder locking, the Occluder is still
attached to the Delivery System by the Retrieval Cord.
During the Occluder locking step, the Delivery Catheter moves
proximally and may exert minimal tension on the introducer sheath.
It is recommended to confirm adequate introducer sheath insertion
prior to Occluder locking.
3. If the Occluder position is not acceptable, refer to Section H, “Removing the
Occluder with the Retrieval Cord After Occluder Locking”.
4. If the Occluder position is acceptable, hold the Handle in a fixed position,
pull up on the red Retrieval Cord Lock (Figure 8a), disengage it from the
Slider, and gently pull the Retrieval Cord Lock until the Retrieval Cord has
been completely removed from the Handle (Figure 8b).
5. The Occluder is now released from the Delivery System and the Delivery
System can be removed.
6. Once the Retrieval Cord is removed, the Occluder cannot be removed using
the Delivery System, refer to Section I, "Recapture".
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