Intended Use; Contraindications - COOK Medical FORMULA 418 Gebrauchsanweisung

Order Number
FOV418-18-135-3-20
FOV418-18-135-3-24
FOV418-18-135-3-30
FOV418-18-135-4-12
FOV418-18-135-4-16
FOV418-18-135-4-20
FOV418-18-135-4-24
FOV418-18-135-4-30
FOV418-18-135-5-12
FOV418-18-135-5-16
FOV418-18-135-5-20
FOV418-18-135-5-24
FOV418-18-135-5-30
FOV418-18-135-6-12
FOV418-18-135-6-16
FOV418-18-135-6-20
FOV418-18-135-6-24
FOV418-18-135-6-30
FOV418-18-135-7-12
FOV418-18-135-7-16
FOV418-18-135-7-20
FOV418-18-135-7-24
FOV418-18-135-7-30
FOV418-18-135-8-12
FOV418-18-135-8-16
FOV418-18-135-8-20
FOV418-18-135-8-24
FOV418-18-135-8-30
*See manufacturer specifications for French (Fr) equivalent.

INTENDED USE

The Formula 418 Vascular Balloon-Expandable Stent System is intended for stenting of peripheral arteries.

CONTRAINDICATIONS

The Formula 418 Vascular Balloon-Expandable Stent System is contraindicated for use in:
• Patients for whom antiplatelet and/or anticoagulant therapy is contraindicated.
• Patients who have a lesion that cannot be crossed with a wire or a balloon angioplasty catheter.
• Patients who have stenoses that cannot be dilated to permit passage of the stent.
• Patients with bleeding disorders.
• Stenting of an arterial vessel where leakage from the artery could be exacerbated by placement of a stent.
• Patients with a target lesion with a large amount of adjacent acute or subacute thrombus.
WARNINGS
• The use of this device carries the associated risks of subacute thrombosis, vascular complications and/or bleeding
events. Judicious selection of patients is necessary.
• Persons allergic to 316L stainless steel may suffer an allergic reaction to this implant.
• The stent should not be placed in a location with significant external compression which could crush the stent.
• The stent should not be deployed in areas subject to significant flexure or bending to reduce the risk of stent
deformations or fracture.
Catheter Stent
Length Diameter
(cm) (mm)
135 3
135 3
135 3
135 4
135 4
135 4
135 4
135 4
135 5
135 5
135 5
135 5
135 5
135 6
135 6
135 6
135 6
135 6
135 7
135 7
135 7
135 7
135 7
135 8
135 8
135 8
135 8
135 8
Minimum Guiding
Stent
Catheter/Sheath*
Length
Inside Diameter
(mm)
20
24
30
12
16
20
24
30
12
16
20
24
30
12
16
20
24
30
12
16
20
24
30
12
16
20
24
30
4
Guiding
Catheter/
Sheath
(French
(inches)
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.068 6.0/5.0
0.078 7.0/6.0
0.078 7.0/6.0
0.078 7.0/6.0
0.078 7.0/6.0
0.078 7.0/6.0
0.078 7.0/6.0
0.078 7.0/6.0
0.078 7.0/6.0
0.078 7.0/6.0
0.078 7.0/6.0
size)