Stryker Surpass Evolve Gebrauchsanweisung Seite 6

3. Resheathing instructions: If positioning is not satisfactory, the implant can be
recaptured and repositioned as long as the distal marker on the microcatheter
is not proximal to the resheathing marker on the delivery wire. To recapture
the implant, simultaneously advance the microcatheter while gently pulling
back on the delivery wire.
caution: Do not attempt to partially deploy and recapture the implant more
than three times or a loss of resheath performance may occur.
caution: Do not apply excessive force if significant resistance is experienced
while attempting to recapture the implant or a failure of the device may occur.
4. After about 10mm of the implant has been deployed, its distal end will begin to
flare and appose to the vessel walls.
5. After the distal end of the implant has successfully expanded and begun
apposing to the vessel walls, deploy the remainder of the implant by
alternately pushing the delivery wire and retracting the microcatheter.
Carefully monitor the delivery wire distal tip under fluoroscopy during
deployment of the implant. Once the operator has passed the resheath marker,
the implant should be unsheathed without pushing on the delivery wire.
6. After the entire implant has deployed, confirm full expansion under
fluoroscopy and ensure that it has completely apposed the vessel wall. If the
device is not fully apposed, consider using a balloon catheter to fully open it.
7. Advance the microcatheter over the delivery wire through the deployed
implant, being careful not to dislodge the implant, until the radiopaque marker
on the microcatheter tip is distal to the deployed implant. Retract the delivery
wire into the microcatheter.
8. Verify that the device has remained patent and properly positioned.
9. After completing the procedure, dispose of all devices in accordance with
hospital, administrative and/or local government policy.
Frequently asked Questions (FaQ)
Q. If excessive friction is experienced during the insertion of the delivery system
into the microcatheter, what should I do?
A. Carefully remove the entire system simultaneously (microcatheter and
delivery system).
Q. Can I retrieve the implant if the distal end has deployed at an undesirable
location?
A. Yes. A partially deployed implant can be resheathed. Carefully pull back the
delivery wire while simultaneously advancing the microcatheter until the
implant is secured inside the microcatheter. Then, if there is no resistance,
simultaneously remove the entire system (microcatheter and delivery system).
Q. Can I retrieve a fully deployed implant?
A. Once fully deployed, the implant cannot be removed. A second implant can be
deployed, if needed.
Q. Can I place a second implant inside another implant?
A. Yes. A second implant can be placed inside another. After placing the first
implant, advance the microcatheter over the delivery wire while keeping
the delivery wire across the neck of the intracranial aneurysm. Position the
microcatheter at the desired location and retrieve the delivery wire. Select a
new appropriate implant and deploy it as normal.
Black (K) ∆E ≤5.0
warning: Placement of multiple Surpass Evolve™ Flow Diverters may
increase the risk of ischemic complications.
Q. If there is a difference between the proximal and distal vessel diameters,
which Surpass Evolve Flow Diverter System diameter do I choose?
A. Choose a system that matches the larger (typically proximal) vessel diameter
to ensure proper anchoring.
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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