Stryker Surpass Streamline Gebrauchsanweisung Seite 5

• Anchoring the guidewire tip in a safe location distal to the lesion may help enhance
support during deployment.
• Keep the guidewire tip and guide catheter tip visible on screen at all times during
exchange technique.
• Confirm appropriate positioning of the guide catheter and intermediate catheter -
retreating catheters can make it more difficult to advance the system.
6. The Surpass™ Flow Diverter is now ready to be deployed.
Flow Diverter Positioning (Direct technique)
1. Use standard catheter and guidewire access techniques to position an intermediate
catheter with an ID of no less than 0.053 in proximal to, or if needed, distal to the
aneurysm neck.
2. Remove the wire used in step 1, leaving the catheter in position.
3. Outside the patient, carefully load the Delivery System onto a 0.014 in access length
guidewire.
4. Under fluoroscopic guidance, carefully simultaneously advance both the Delivery System
and the guidewire through the catheter until the Delivery System is past the aneurysm
location.
5. If needed, pull the intermediate catheter back while keeping the Delivery System in place
across the neck of the aneurysm.
6. Confirm the position of the Surpass Flow Diverter by visualizing the radiopaque implant.
6.1 Unsheathing Technique - Make sure the distal end of the implant is at least 5mm past
the distal neck of the aneurysm.
6.2 Push/Pull Technique - Make sure that the distal marker on the Surpass Streamline™
outer is at least 5 mm past the neck of the aneurysm.
Notes:
• P ulling back on the Delivery System to make final adjustments will ensure that slack
has been removed from the Delivery System prior to deployment.
• Keep the system as straight as possible outside of the patient.
• If difficulty in access is noticed especially when crossing the neck of the aneurysm
or a bifurcation, ensure the two distal marker bands (Surpass Streamline outer and
Surpass Streamline pusher) are aligned with minimal gap by gently retracting or
advancing the Surpass Streamline pusher.
• Interchanging forward movements with the intermediate catheter and the Delivery
System may improve navigation.
• Anchoring the guidewire tip in a safe location distal to the lesion may help enhance
support during deployment.
• Confirm appropriate positioning of the guide catheter and intermediate catheter -
retreating catheters can make it more difficult to advance the system.
7. The Surpass Flow Diverter is now ready to be deployed.
Flow Diverter Deployment
1. Loosen the RHV on the Surpass Streamline outer.
1.1 Unsheathing Technique - Begin deployment by pulling the Surpass Streamline outer
while putting slight forward pressure on the Surpass Streamline pusher until the
Surpass Flow Diverter begins to exit the Surpass Streamline outer and starts apposing
to the vessel wall.
1.2 Push/Pull Technique - Begin deployment by pushing on the Surpass Streamline pusher
until the distal end of the Surpass Flow Diverter is aligned with the distal marker on
the Surpass Streamline outer, then pull the Surpass Streamline outer while putting
slight forward pressure on the Surpass Streamline pusher until the Surpass Flow
Diverter begins to exit the Surpass Streamline outer and starts apposing to the
vessel wall.
2. A combination of forward pressure (pushing) on the Surpass Streamline pusher and/or
retraction of the Surpass Streamline outer (pulling) should enable the operator to keep
the distal end of the implant aligned at the desired landing zone.
Note: During deployment, to improve apposition, tighten the RHV on the Surpass
Streamline outer and advance the system to maintain slight forward pressure on the
Surpass Flow Diverter.
3. If positioning is not satisfactory, the Surpass Flow Diverter can be recaptured and
repositioned. To recapture the Surpass Flow Diverter, alternately advance the Surpass
Streamline outer and pull the Surpass Streamline pusher. Once recaptured, the
Delivery System can be repositioned both distally and proximally.
Note: The Surpass Flow Diverter can be recaptured as long as the gap between Surpass
Streamline outer tip marker and proximal Surpass Streamline pusher marker is at least
11mm.
Caution: Do not attempt to partially deploy and recapture the Surpass Flow Diverter more
than three times.
Caution: Do not attempt to move the Surpass Flow Diverter more distally once it has begun
to appose the vessel walls.
Caution: Do not apply additional force if significant resistance is experienced while
attempting to recapture the flow diverter.
4. If the position of the Delivery System is satisfactory, refer back to Flow Diverter
deployment Steps 1.1/1.2 to begin deployment. After about 10 mm of the Surpass Flow
Diverter has been exposed, its distal end will begin to flare and appose the vessel walls.
5. After the distal end of the Surpass Flow Diverter has successfully expanded and
begun apposing the vessel walls, deploy the remainder of the Surpass Flow Diverter by
alternately pushing the Surpass Streamline pusher and pulling on the Surpass Streamline
outer. Carefully monitor the Surpass Streamline pusher tip under fluoroscopy during
deployment of the Surpass Flow Diverter.
6. After the entire Surpass Flow Diverter has deployed, confirm full expansion under
fluoroscopy to ensure that it has completely apposed the vessel wall.
7. Advance the Surpass Streamline outer over the Surpass Streamline pusher until the
radiopaque marker on the Surpass Streamline pusher tip is aligned with the distal
radiopaque marker on the Surpass Streamline outer. Tighten the Surpass Streamline
outer RHV.
8. Carefully remove the Delivery System and accessories as a unit and discard.
9. Verify that the device has remained patent and properly positioned.
10. After completing the procedure, withdraw and discard all applicable accessory devices.
WARRANTY
Stryker Neurovascular warrants that reasonable care has been used in the design and
manufacture of this instrument. This warranty is in lieu of and excludes all other warranties
not expressly set forth herein, whether express or implied by operation of law or otherwise,
including, but not limited to, any implied warranties of merchantability or fitness for a
particular purpose. Handling, storage, cleaning and sterilization of this instrument as well
as other factors relating to the patient, diagnosis, treatment, surgical procedures and other
matters beyond Stryker Neurovascular's control directly affect the instrument and the results
obtained from its use. Stryker Neurovascular's obligation under this warranty is limited to the
repair or replacement of this instrument and Stryker Neurovascular shall not be liable for
any incidental or consequential loss, damage or expense directly or indirectly arising from
the use of this instrument. Stryker Neurovascular neither assumes, nor authorizes any other
person to assume for it, any other or additional liability or responsibility in connection with
this instrument. Stryker Neurovascular assumes no liability with respect to instruments
reused, reprocessed or resterilized and makes no warranties, express or implied, including
but not limited to merchantability or fitness for a particular purpose, with respect to such
instruments.
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Black (K) ∆E ≤5.0