Stryker Neuroform Atlas Instrucciones De Uso página 3

Therefore, the stent is not designed to treat an aneurysm with a neck greater
than 22 mm in length.
• If excessive resistance is encountered during the use of the Neuroform Atlas™
Stent System or any of its components at any time during the procedure,
discontinue use of the stent system. Continuing to move the stent system
against resistance may result in damage to the vessel or a system component.
• Persons allergic to nickel titanium (Nitinol) may suffer an allergic response to
this stent implant.
table 2. stent sizing
stent Label Diameter: 3.0 mm
Labeled stent Length
15 mm 21 mm
vessel
wL tL wL
Diameter
(mm) (mm) (mm)
(mm)
2.0 15.4 17.6 22.6
15.4 17.6 22.3
2.5
3.0 15.2 17.4 22.0
stent Label Diameter: 4.0 mm
Labeled stent Length
15 mm 21 mm
vessel
wL tL wL
Diameter
(mm) (mm) (mm)
(mm)
3.0 15.1 17.3 21.7
14.8 17.1 21.0
3.5
4.0 14.6 16.8 20.4
stent Label Diameter: 4.5 mm
Labeled stent Length
15 mm 21 mm
vessel
wL tL wL
Diameter
(mm) (mm) (mm)
(mm)
4.0 14.6 16.3 20.8
4.5 14.3 16.1 20.0
WL = Working Length, TL = Total Length (Refer to figure 3.)
Figure 3: working Length (wL)/ total Length (tL)
24 mm 30 mm
tL wL tL wL tL
(mm) (mm) (mm) (mm) (mm)
24.4 25.5 27.3 31.5 33.6
24.3 25.0 27.2 31.1 33.3
24.2 24.7 26.8 30.8 33.1
24 mm 30 mm
tL wL tL wL tL
(mm) (mm) (mm) (mm) (mm)
23.6 24.5 26.6 30.8 32.9
23.2 24.1 26.3 30.4 32.6
22.5 23.8 25.4 29.2 31.4
24 mm 30 mm
tL wL tL wL tL
(mm) (mm) (mm) (mm) (mm)
23.1 23.7 25.8 29.9 32.3
22.2 23.1 25.2 29.5 31.8
preCaUtIons
• Use the Neuroform Atlas Stent System prior to the "Use By" date printed on the
package.
• Carefully inspect the sterile package and Neuroform Atlas Stent System prior to
use to verify that neither has been damaged during shipment. Do not use kinked
or damaged components; contact your Stryker Neurovascular representative.
• The stent delivery microcatheter and the Neuroform Atlas Stent delivery wire
should not be used to recapture the stent.
• Exercise caution when crossing the deployed stent with adjunctive devices.
• After deployment, the stent may foreshorten up to 6.3%.
• The max OD of the coiling microcatheter should not exceed the max OD of the
stent delivery microcatheter.
• Standard interventional devices with distal tips > 1.8 F may not be able to pass
through the interstices of the stent.
aDverse events
potential adverse events
Potential complications include, but are not limited to:
• allergic reaction to Nitinol metal and medications
• aneurysm perforation/rupture
• coil herniation through stent into parent vessel
• death
• embolus
• hemorrhage
• in-stent stenosis
• infection
• ischemia
• neurological deficit / intracranial sequelae
• pseudoaneurysm
• recanalization requiring retreatment
• stent fracture
• stent migration/embolization
• stent misplacement
• stent thrombosis
• stroke
• transient ischemic attack
• vasospasm
• vessel occlusion or closure
• vessel perforation/rupture, dissection, trauma or damage
• vessel thrombosis
• other procedural complications including but not limited to anesthetic and
contrast media risks, hypotension, hypertension, access site complications.
Refer to the appropriate embolic coil DFU for other complications that may occur
due to coil embolization.
3
Black (K) ∆E ≤5.0