Medtronic Valiant Navion Gebrauchsanweisung Seite 19

Caution: Initiating deployment of the stent graft with the tip capture release handle in its unlocked position (rotated
counterclockwise) may result in premature release of the proximal end.
9.4. Introducing the delivery system
1. If necessary, open narrow entry vessels with standard percutaneous transluminal angioplasty catheters or vessel dilators
before Valiant Navion thoracic stent graft implantation according to standard endovascular procedures. If necessary, dilate
the vessel with a tapered vessel dilator. A stepup approach is recommended for vessel dilation, at the discretion of the
physician.
2. Insert the delivery system over the guidewire. Before insertion into the vessel, activate the hydrophilic coating by wiping the
outer surface of the graft cover with a sterile gauze saturated in saline, until the graft cover is slippery to touch.
Note: The delivery system does not require a separate introducer sheath for the primary access site. If a separate
introducer sheath is used, refer to the Instructions for Use supplied with the introducer sheath for more information.
Caution: Manipulation of guidewires, balloons, catheters, and endografts in the thoracic aorta may lead to vascular trauma,
including aortic dissection and embolization.
Caution: Do not bend, kink, or otherwise alter the delivery system before implantation because it may cause deployment
difficulties.
Caution: If an obstruction in the vessel, such as a tortuous bend, stenosis, or calcification formation, prevents advancement of
the delivery system, do not use excessive force to advance the delivery system. The cause of the resistance must be assessed
in order to avoid vessel or delivery catheter damage.
Caution: Do not grip the tip capture release handle while introducing the delivery system.
Warning: Do not advance the delivery system without placing a guidewire, and do not remove the guidewire while the delivery
system is in the patient.
9.5. Positioning the delivery system
1. Slowly advance the delivery system to the targeted landing zone.
2. Position the delivery system by tracking to target location.
Caution: Avoid positioning the device higher in the presence of excessive calcification or thrombus, due to the increased risk of
dislodging material while distally repositioning of the stent graft.
Caution: Avoid or compensate for parallax or other sources of visualization error.
Caution: Do not advance the delivery system tip or guidewire across the aortic valve.
Caution: Do not grip the tip capture release handle while positioning the delivery system.
Note: Stent graft may also be tracked proximal to targeted landing zone.
Figure 4. Tip capture release handle in locked position
Figure 5. Introducing the delivery system
Instructions for Use English 17