Stryker Neuroform EZ Mode D'emploi

90835177-01
Neuroform EZ
Stent System
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
warning
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is
damaged. If damage is found, call your Stryker Neurovascular representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization
may compromise the structural integrity of the device and/or lead to device failure which, in turn,
may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a
risk of contamination of the device and/or cause patient infection or cross-infection, including, but
not limited to, the transmission of infectious disease(s) from one patient to another. Contamination
of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative and/or
local government policy.
resale of this device is prohibited by US law.
DEViCE DESCriPTiOn
The Neuroform EZ Stent System includes:
• A self-expanding, nitinol stent with four radiopaque markerbands on each end (distal and
proximal) and 3 interconnects between the central stent segments, designed to provide
support of the coil mass within the aneurysm and minimize stent deflection.
• A stent delivery wire. The stent is pre-loaded on the stent delivery wire and protected by an
introducer sheath.
• An accessory pouch containing an optional guidewire introducer and an optional torque
device. The physician may attach the torque device to the proximal end of the stent delivery
wire, which may facilitate handling and stabilization. The stent delivery wire is not designed
to be torqued. The guidewire introducer should not be used with the stent delivery wire. If the
microcatheter must be repositioned with a guidewire (as described in procedure step 18),
the guidewire introducer may be used to facilitate introduction into the microcatheter.
Contents
• One (1) Neuroform EZ Stent System
• One (1) Torque Device
• One (1) Guidewire Introducer
1 cm
1.9 cm
45 cm
Stent
45º
Radiopaque
Tip Radiopaque
Bumper
Figure 1. neuroform EZ Stent System
Directions for Use........ 1
Mode d'emploi.............. 6
For Canada Only
2017-06
< >
Canada
™
185 cm
135 cm
Fluoro Saver Mark
Radiopaque
Bumper
Table 1. Sizing Table
Labeled Stent Diameter Self Expanded Stent Diameter
(mm) (mm)
2.5 3.0
3.0 3.5
3.5 4.0
4.0 4.5
4.5 5.0
Select a stent diameter based on the sizing recommendations in Table 1 and based on the larger vessel diameter (proximal or distal
1
reference vessel diameter).
inTEnDED USE/inDiCaTiOnS FOr USE
The Neuroform EZ Stent System is intended for use with embolic coils for the treatment of wide
neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ≥ 2 mm
and ≤ 4.5 mm that are not amenable to treatment with surgical clipping. Wide neck aneurysms are
defined as having a neck ≥ 4 mm or a dome-to-neck ratio of < 2.
COnTrainDiCaTiOn
• Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
• Patients for whom angiography and other examinations show that access to the target
cerebral aneurysm by the stent may be impossible because of anatomical features, or severe
vascular spasm that does not respond to pharmacological therapy.
warningS
• This device should only be used by physicians who have received appropriate training in
interventional neuroradiology or interventional radiology and preclinical training on the use of this
device as established by Stryker Neurovascular.
• Select a stent size (length and diameter) to maintain a minimum of 4 mm on each side of the
aneurysm neck along the parent vessel. An incorrectly sized stent may result in damage to the
vessel or stent migration. 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 EZ 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.
• The Neuroform EZ Stent System should not be used for the treatment of stenosis due to
intracranial atherosclerotic disease.
• Persons allergic to nickel titanium (Nitinol) or platinum may suffer an allergic response to this
stent implant.
PrECaUTiOnS
• The Neuroform EZ Stent System is provided STERILE for single use only.
• Use the Neuroform EZ Stent System prior to the "Use By" date printed on the package.
• Carefully inspect the sterile package and Neuroform EZ Stent System prior to use to verify that
neither has been damaged during shipment. Do not use kinked or damaged components.
• Please refer to "Magnetic Resonance Imaging (MRI) Compatibility" section for MRI
Information.
• The Neuroform EZ Stent System should not be used for recapturing the stent.
• Exercise caution when crossing the deployed stent with adjunct devices.
• After deployment, the stent may foreshorten up to 1.8% in 2.5 mm stents and up to 5.4% in
4.5 mm stents.
• The safety of the Neuroform EZ Stent System in patients below the age of 18 has not been
established.
• In cases where multiple aneurysms are to be treated, start at the most distal aneurysm first.
• The safety of "Y" stenting or techniques of passing a guidewire through stent interstices to
access other vessels for the purpose of stenting has not been clinically established.
aDVErSE EVEnTS
Potential adverse Events
Potential complications include, but are not limited to:
• Allergic reaction including, but not limited to, contrast, Nitinol, platinum and medications
• Aneurysm perforation/rupture
• Coil herniation through stent into parent vessel
• Death
recommended Vessel Diameter
1
(mm)
> 2.0 and ≤ 2.5
> 2.5 and ≤ 3.0
> 3.0 and ≤ 3.5
> 3.5 and ≤ 4.0
> 4.0 and ≤ 4.5
Black (K) ∆E ≤5.0