How Supplied; Operational Instructions - Stryker Neuroform EZ Mode D'emploi

Table 13. Summary of neurological Status
Neurological
Status at 6 months compared to Baseline
Assessment
Modified No change
Rankin Scale
Worse
Improved
Barthel No change
Worse
Improved
NIHSS No change
Worse
Improved
One patient discontinued (withdrew consent) and is not included.
1
In one subject with partial hemianopsia, the visual field deteriorated from a score of 0
2
before the procedure to a score of 1, 7 days, 30 days and 6 months after the procedure.
PaTiEnT inFOrMaTiOn
You should have already provided the patient with a copy of
the Patient Information Booklet so that (s)he has had adequate
time to review the information and ask any questions.
Immediately after the procedure, complete the Patient
Information Card, which is included in the Patient Information
Booklet, and provide the card to the patient before the patient
leaves the hospital. The Patient Information Card includes
important information about the stent that was used and
includes a statement regarding MRI information.
COnCOMiTanT MEDiCaL THEraPY
Typical antiplatelet and anticoagulation regimen used for
interventional intracranial procedure is recommended
at the discretion of the treating physician. Do not use the
Neuroform EZ™ Stent System in patients in whom antiplatelet
and/or anticoagulation therapy is contraindicated.
MagnETiC rESOnanCE iMaging (Mri) COMPaTibiLiTY
Magnetic resonance Conditional
Non-clinical testing and analysis have demonstrated that
Neuroform Stent is MR Conditional alone, or when overlapped
®
with a second stent, and adjacent to a Stryker Neurovascular
coil mass. A patient with Neuroform Stent can be safely
scanned immediately after placement of this implant, under the
following conditions:
• static magnetic field of 1.5 and 3.0 Tesla
• spatial gradient field up to 2500 Gauss/cm (25 Tesla/m)
• normal operational mode for gradients and SAR (maximum
whole body averaged specific absorption rate (SAR) of
lower than 2.0 W/kg and maximum head SAR of lower
than 3.2 W/kg) for a total active MR scan time (with RF
exposure) of 15 minutes or less per scan sequence.
In an analysis based on the temperature rises in non-clinical
testing of stents and the calculated SAR in the patient during
an MR scan, Neuroform Stents were determined to produce
an in-vivo temperature rise of 4°C or lower for 15 minutes of
MR scanning in normal operational mode in 1.5 T and 3 T MR
systems. The Neuroform Stent should not migrate in this MRI
environment.
MR image quality may be compromised if the area of interest
is in the same area or relatively close to the position of the
device. In Spin Echo and Gradient Echo sequence evaluations
Neuroform stent image artifact extended approximately 2 mm
from the device. Lumen of the stent was partially obscured by
the artifact. Therefore, it may be necessary to optimize MR
imaging parameters for the presence of this implant.

HOw SUPPLiED

Minimum Materials required (not included in the
neuroform EZ Stent System package)
Quantity Material
1 Appropriate guiding catheter(s)
[0.064 in (1.63 mm) minimum ID]
3 S terile Heparinized normal saline (HepNS)
flush lines 1000 U/500 mL (500 cc)
1 0.014 in (0.36 mm) guidewire access length
1 0.014 in (0.36 mm) guidewire exchange length
1 Sterile Contrast
1 Arterial sheath and dilator set
1 20 mL (20 cc) syringe with luer-lock
3 Three way stopcock
1 0 .027 in (0.69 mm) ID Microcatheter, 135 or 150 cm
1
length
Do not use if package is opened or damaged.
89.5% (17/19)
Do not use if labeling is incomplete or illegible.
5.3% (1/19)
Handling and Storage
5.3% (1/19)
Store in a cool, dry, dark place.
100% (19/19)

OPEraTiOnaL inSTrUCTiOnS

0%
initial access, angiographic assessment and Stent Selection
0%
1. Gain vascular access according to standard practice. Select
a Boston Scientific or Stryker Neurovascular microcatheter
94.7% (18/19)
(0.027 in / 0.69 mm ID and 135 or 150 cm length) with a
5.3% (1/19)
2
neurovascular indication. Establish and maintain continuous
flush with sterile heparinized saline through the microcatheter
0%
per standard vascular practice. Using angiography, determine
the location of the aneurysm and the size of the aneurysm neck.
2. Navigate the microcatheter over an access length guidewire at
least 1.2 cm distal to the aneurysm neck.
note: The microcatheter tip must be placed sufficiently distal
to the aneurysm neck to allow for slack to be removed from the
system after the stent is advanced, while maintaining adequate
stent length (approximately 4 mm) distal to the aneurysm
neck. Excessive tortuosity may necessitate microcatheter tip
placement more than 1.2 cm distal to the aneurysm neck.
3. Remove the guidewire.
4. Select an appropriate Neuroform EZ Stent System based on
the sizing recommendations in Table 1 and based on the larger
reference vessel diameter. Select a stent that is at least 8 mm
longer than the aneurysm neck to maintain a minimum of 4 mm
on each side of the aneurysm neck along the parent vessel.
Delivery System Preparation and Stent Transfer
5. Carefully inspect the stent system packaging for damage. Do
not use if damage is found; call your Stryker Neurovascular
representative.
6. Peel open the pouch using aseptic technique.
7. Carefully place the dispenser hoop into the sterile field.
8. Release the stent delivery wire from the clip on the dispenser
hoop. Hold the stent delivery wire and proximal end of the
introducer sheath together, then carefully remove the system
from the dispenser hoop.
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 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 indicate an inadequately tightened RHV and 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.
4
Black (K) ∆E ≤5.0