Stryker Neuroform EZ Gebrauchsanweisung Seite 2

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 law.
DEVICE DESCrIPTIOn
The Neuroform EZ Stent System includes:
• A self-expanding, open cell, nitinol stent with four radiopaque markerbands on each end (proximal and
distal) 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
45º
Stent
Radiopaque
Radiopaque
Tip
Bumper
Figure 1. neuroform EZ Stent System
Black (K) ∆E ≤5.0
™
185 cm
135 cm
Fluoro Saver Mark
Radiopaque
Bumper
Table 1. Sizing Table
Labeled Stent Diameter Self Expanded Stent Diameter
(mm)
2.5
3.0
3.5
4.0
4.5
Select a stent diameter based on the sizing recommendations in Table 1 and based on the larger vessel diameter (proximal or
1
distal reference vessel diameter).
InTEnDED USE/InDICaTIOnS FOr USE
The Neuroform EZ Stent System is authorized by European law for use with occlusive devices in the treatment
of intracranial aneurysms.
COnTraInDICaTIOn
• Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
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.
• Persons allergic to nickel titanium (Nitinol) 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.
• For MRI information, please refer to the "MRI Information" section.
• 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
• aneurysm perforation/rupture
• coil herniation through stent into parent vessel
• death
• embolus
• hemorrhage
• in-stent stenosis
• infection
• ischemia
• neurological/intracranial sequelae
• pseudoaneurysm
2
recommended Vessel Diameter
(mm) (mm)
3.0 > 2.0 and ≤ 2.5
3.5 > 2.5 and ≤ 3.0
4.0 > 3.0 and ≤ 3.5
4.5 > 3.5 and ≤ 4.0
5.0 > 4.0 and ≤ 4.5
1