Questions And Answers - Stryker Neuroform EZ Instrucciones De Uso

note: The stent delivery wire and proximal end of the introducer sheath must be held together when
removing the Neuroform EZ™ Stent System from the dispenser hoop to prevent stent movement and
premature deployment.
note: Confirm that the stent delivery wire does not move relative to the introducer sheath during removal
of the stent system from the dispenser hoop.
9. Inspect the stent system. Confirm that the tip of the stent delivery wire is entirely within the introducer
sheath. Confirm that the stent delivery wire is not kinked and that the introducer sheath tip is not
damaged. Do not use if damage is found; call your Stryker Neurovascular representative.
10. Partially insert the distal end of the introducer sheath into the RHV (3.5F compatible RHV) connected
to the microcatheter. Tighten the RHV. Open the y-connector valve of the RHV that is connected to the
sterile heparinized saline flush and verify that fluid exits the proximal end of the introducer sheath.
warning: Purge the system carefully to avoid the accidental introduction of air into the stent system.
note: Partial insertion of the introducer sheath into the RHV is necessary to ensure a flow path for flush.
11. Loosen the RHV. Advance the introducer sheath until the colored tip is fully inserted into the
microcatheter hub, then tighten the RHV firmly. Pull gently on the introducer sheath to ensure that it is
secure. The introducer sheath tip should not move.
warning: Confirm there are no air bubbles trapped anywhere in the stent system.
note: After tightening the RHV firmly, the introducer sheath tip should not move when pulled gently.
Failure to secure the introducer sheath may result in premature deployment of the stent within the
microcatheter hub or difficulty in transferring the stent.
note: The introducer sheath colored tip must be fully inserted into the microcatheter hub to enable the
stent to move into the microcatheter. Over-tightening the RHV may crush the introducer sheath, while
under-tightening the RHV may indicate an inadequately tightened RHV and may result in premature
deployment of the stent.
12. Advance the stent delivery wire to transfer the stent from the introducer sheath into the microcatheter.
note: Ensure that the introducer sheath does not move while advancing the stent delivery wire.
Movement of the introducer sheath during stent advancement may result in premature deployment of
the stent within the microcatheter hub.
13. Continue advancing the stent delivery wire into the microcatheter until the distal edge of the white fluoro
saver mark enters the introducer sheath. The white fluoro saver mark is 135 cm from the stent delivery
wire distal tip. When the white fluoro saver mark enters the introducer sheath, the stent is about
90 cm inside the microcatheter.
14. Loosen the RHV, remove the introducer sheath from the proximal end of the stent delivery wire while
holding the stent delivery wire fixed in place, and set introducer sheath aside in sterile field.
note: At this point, fluoroscopy may be used at the physician's discretion.
15. Slowly advance the stent delivery wire until the distal edge of the stent delivery wire fluoro saver mark
reaches the microcatheter's RHV.
Stent Positioning and Deployment
16. Under fluoroscopy, advance the stent delivery wire until the stent's distal radiopaque markers are 1 – 2 mm
from the distal tip marker of the microcatheter.
note: Do not apply undue force if resistance is encountered at any point during stent manipulation. Withdraw
the microcatheter, stent and stent delivery wire as a unit and repeat the procedure with new devices.
17. Withdraw the microcatheter slightly to remove any slack from the stent system and to position the stent
for deployment by aligning the stent radiopaque markers across the target aneurysm.
note: Maintain adequate stent length (approximately 4 mm) on each side of the aneurysm neck to
ensure appropriate neck coverage.
18. Before stent deployment, if the microcatheter must be repositioned with a guidewire, the stent and the
stent delivery wire must be pulled back into the introducer sheath as follows: Tighten the RHV firmly to
hold the stent delivery wire and the microcatheter together, then reposition the distal flexible segment of
the catheter until it is in a relatively straight segment of the artery. Load the introducer sheath over the
proximal end of the stent delivery wire into the RHV attached to the microcatheter, and ensure that the
colored tip is fully inserted into the microcatheter hub. Tighten the RHV firmly. Pull gently on the introducer
sheath to ensure that it is secure. The introducer sheath tip should not move.
Carefully retract the stent delivery wire so that the stent is pulled back into the introducer sheath
proximal to the colored tip section. Verify that the sterile heparinized saline flush exits the introducer
sheath to ensure that no blood products remain in the sheath. Ensure that the distal tip of the stent
delivery wire is fully inside the introducer sheath, then loosen the RHV and remove the stent system
from the RHV. Once the stent system is removed from the microcatheter, place the stent system in sterile
heparinized saline for reuse after microcatheter repositioning. Re-insert the access length guidewire to
reposition the microcatheter, using the guidewire introducer if desired.
note: At least 50 cm of the stent delivery wire should be proximal to the RHV in order to load the
introducer sheath.
note: Be careful that the introducer sheath is loaded in the correct orientation – the colored tip should
be fully inserted into the hub of the microcatheter.
note: After tightening the RHV firmly, the introducer sheath tip should not move when pulled gently.
Failure to secure the introducer sheath may result in premature deployment of the stent within the
microcatheter hub or difficulty in transferring the stent.
note: Ensure that the introducer sheath does not move while retracting the stent delivery wire.
Movement of the introducer sheath during stent retraction may indicate an inadequately tightened RHV
and may result in premature deployment of the stent within the microcatheter hub.
19. If stent positioning is satisfactory, carefully retract the microcatheter in a continuous movement,
while maintaining the position of the stent delivery wire to allow the stent to deploy across the
neck of the aneurysm. The stent's distal markers will expand as it exits the microcatheter. Confirm
deployed stent position.
note: Do not deploy the stent if it is not properly positioned in the vessel.
note: The physician may attach the optional torque device to the proximal end of the stent delivery
wire, which may facilitate handling and stabilization. Be sure to tighten the torque device to secure
the stent delivery wire. Do not use the torque device to torque the stent delivery wire as it is not
designed to be torqued.
note: Do not use the stent delivery wire to push the stent out of the microcatheter while deploying.
20. Prior to removing the stent delivery wire, position the microcatheter distal to the stent to maintain
access through the stent. Remove and discard the Neuroform EZ Stent System.
21. Advance an exchange length guidewire through the microcatheter.
22. Remove the 0.027 in microcatheter while maintaining the position of the exchange length guidewire, and
replace with an appropriate microcatheter to begin aneurysm embolization.
aneurysm Embolization
23. The aneurysm embolization can begin immediately. Standard microcatheters accepting 0.25 mm (0.010 in),
0.36 mm (0.014 in), or 0.46 mm (0.018 in) guidewires with distal tip ≤ 2F may be carefully placed through the
interstices of the stent to place embolic coils in the aneurysm.
note: Carefully watch the stent markerbands when passing through the deployed stent with embolic
coiling microcatheters to avoid dislodging the stent.
24. Perform a standard embolic coiling procedure using accepted embolic coiling practices.

QUESTIOnS anD anSwErS

Q: What is the optimal position of the stent with respect to the aneurysm?
A: Generally, try to position the stent so that each end of the stent is secured in relatively normal areas of
the parent vessel. The stent will be more stable if each end of the stent is anchored in at least 4-6 mm of
normal vessel. For example, for aneurysms located in the supraclinoid carotid, it may be better to secure
the stent by deploying the distal end in the M1 (middle cerebral artery, first segment) than trying to
deploy it in the few millimeters between the aneurysm and the ICA (internal carotid artery) bifurcation.
When deploying the stent, care should be taken to use a view that best shows the parent vessel distal
to the aneurysm, so that the distal end of the stent can be accurately deployed with respect to the
aneurysm. This view may be different from the view used to advance the Neuroform EZ Stent System, or
the view used as a working position for aneurysm embolization.
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Black (K) ∆E ≤5.0