Medtronic Valiant Navion Gebrauchsanweisung Seite 15

■
All lengths and diameters of the devices necessary to complete the procedure, especially when preoperative case planning
measurements (treatment diameters/lengths) are not certain. This approach allows for greater intraoperative flexibility to
achieve optimal procedural outcomes.
■
Assorted angiographic catheters, angioplasty catheters, graduated pigtail catheters
■
Contrast media
■ Fluoroscope with digital angiography capabilities and the ability to record and recall imaging
■
Surgical suite in the event that emergency open conversion surgery is necessary
■
Heparin and heparinized saline solution
■
Transesophageal echocardiography (TEE)
■
Intravascular ultrasound catheter (IVUS)
■ Introducer sheaths for vascular access and to perform diagnostic imaging
■
Radiopaque ruler
■
Reliant stent graft balloon catheter and other materials recommended by the Reliant Instructions for Use
■
Sterile lubricant
■
An assortment of stiff 0.035 in (0.89 mm) diameter guidewires, ≥ 260 cm in length
6.3. Recommended device sizing
Medtronic recommends that the Valiant Navion thoracic stent graft system be used according to the sizing configurations
provided in Table 2 through Table 5, and the sizing guidelines provided in Table 6 through Table 8. If preoperative case
planning measurements are not certain, an inventory of system lengths and diameters necessary to complete the procedure
should be available to the physician. This approach allows for greater intraoperative flexibility to achieve optimal procedural
outcomes. Using this device outside the recommended anatomical sizing may result in serious device-related adverse events
or clinical events.
The specific stent graft diameter used for treatment should be oversized relative to the nondiseased vessel, using the sizing
guidelines, to ensure appropriate radial fixation. Strict adherence to the sizing guidelines is expected when selecting the
appropriate device size. Table 6 through Table 8 describe the stent graft to vessel oversizing guidelines. Appropriate oversizing
has already been incorporated into the recommended sizes. Additional oversizing should not be incorporated. Sizing outside of
this range can result in endoleak, fracture, migration, infolding, or graft wear.
OD (Fr)
18
20
22
OD (Fr)
18
20
22
Table 2. FreeFlo Straight configurations
Diameter (mm)
20
22
25
28
31
34
37
40
43
46
Table 3. CoveredSeal Straight configurations
Diameter (mm)
20
22
25
28
31
34
37
40
43
46
Covered length (mm)
96
96, 185
97, 174
97, 174, 229
59, 97, 174, 229
62, 103, 183, 223
Covered length (mm)
94
94, 180
90, 182
90, 182, 223
52, 90, 182, 223
55, 95, 175, 218
Instructions for Use English 13