Stryker Neuroform Instrucciones De Uso página 2

Neuroform
Microdelivery Stent System
INTENDED USE/INDICATIONS FOR USE
The Neuroform Microdelivery Stent System is authorized by European law for use with occlusive devices in the
treatment of intracranial aneurysms.
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
DEVICE DESCRIPTION
The Neuroform Microdelivery Stent System includes:
• An ultra-thin, self-expanding, nitinol Stent with four radiopaque markerbands on each end (distal and proximal).
• A flexible over-the-wire 3F Microdelivery Catheter with a distal tip markerband. The Stent is pre-loaded into
the distal end of the 3F Microdelivery Catheter. The Stent is available in a 3 interconnect configuration. The
3 interconnect configuration creates an additional link between the stent cells, provides better support of the
coil mass within the aneurysm, and minimizes stent deflection.
• A 2F Stabilizer Catheter with a distal tip markerband that maintains the Stent position during deployment.
• A Peelable Sheath to aid in the insertion of the guidewire into the 3F Microdelivery Catheter. The Peelable
Sheath is preloaded into the distal end of the 3F Microdelivery Catheter.
• A Rotating Hemostasis Valve, one provided with the 3F Microdelivery Catheter and one provided with the
2F Stabilizer Catheter.
3F Microdelivery Catheter
Stent
2F Stabilizer Catheter Markerband
3F Microdelivery Catheter Markerband
Neuroform Microdelivery Stent System
CONTRAINDICATIONS
• Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated.
WARNINGS
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.
• The Neuroform Microdelivery Stent System should only be used by physicians who have received appropriate
training in interventional neuroradiology and treatment of intracranial aneurysms.
• The Stent is not designed to treat an aneurysm with a neck greater than 22 mm in length. 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.
• The 3F Microdelivery Catheter or the 2F Stabilizer Catheter is not designed or intended for contrast injections.
• If excessive resistance is encountered during the use of the Neuroform Microdelivery Stent System or any of
its components at any time during the procedure, discontinue use of the stent system. Movement of the 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 Microdelivery Stent System is provided STERILE for single use only. Store in a cool, dry place.
• Use the Neuroform Microdelivery Stent System prior to the "Use By" date printed on the package.
• Carefully inspect the sterile package and Neuroform Microdelivery 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 Microdelivery Stent System should not be used for repositioning or recapturing the Stent.
• Exercise caution when crossing the deployed Stent with adjunct devices.
• Do not excessively insert and retract the guidewire through the undeployed Stent because the motion may
remove coating from the guidewire.
• Tighten the Rotating Hemostasis Valves sufficiently to create an adequate hemostasis seal without crushing the
3F Microdelivery Catheter and 2F Stabilizer Catheter shafts. Inadequately tightening the Rotating Hemostasis
Valves may lead to premature deployment of the Stent.
• In tortuous vessels, a stiff guidewire may cause binding within the Neuroform Microdelivery Stent System during
deployment. In such cases, use only soft guidewires, and position the floppy section of the guidewire within the Stent.
• 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.
• Do not steam shape the tip of the 3F Microdelivery Catheter because it could damage the delivery system or stent.
• The safety of the Neuroform Microdelivery Stent System in patients below the age of 18 has not been established.
• Testing on the 30 mm Stents was done only in the lab and not in animals or humans. However, probable benefit
is still expected.
• 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.
Black (K) ∆E ≤5.0
™
Guidewire
2F Stabilizer Catheter
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
• Other procedural complications including but not limited to anesthetic and contrast media risks, hypotension,
hypertension, access site complications
CONCOMITANT MEDICAL THERAPY
Typical antiplatelet and anticoagulation regimen used for interventional intracranial procedure is recommended at
the discretion of the treating physician.
MRI INFORMATION
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
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
Handling and Storage
Store in a cool, dry, dark place.
OPERATIONAL INSTRUCTIONS
Angiographic Assessment of Aneurysm and Stent Selection
1. Using angiography, determine the location of the aneurysm and the size of the aneurysm neck.
2. Select a Stent diameter based on the sizing recommendations in Table 1 and based on the larger vessel
diameter (proximal or distal reference vessel diameter).
3. Select a Stent length 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. Refer to Table 1 for Stent sizing recommendations.
Delivery System Preparation
1. Open and inspect the stent system for damage, such as kinks or compromised packaging. The Stent and
Peelable Sheath should be preloaded into the distal tip of the 3F Microdelivery Catheter.
2. Flush both the 3F Microdelivery Catheter and the 2F Stabilizer Catheter with sterile, heparinized saline.
Note: Care should be taken when flushing the 3F Microdelivery Catheter so that the jet of saline does not push
the Peelable Sheath out of the 3F Microdelivery Catheter.
3. Flush the Rotating Hemostasis Valves and connect to the 2F Stabilizer Catheter.
4. Connect the 2F Stabilizer Catheter and the 3F Microdelivery Catheter to a pressurized sterile heparinized saline flush.
5. Tighten the hemostasis valve on the 3F Microdelivery Catheter to hold the 2F Stabilizer Catheter in place during
advancement of the Neuroform Microdelivery Stent System. Do not overtighten the hemostasis valve because
the 2F Stabilizer Catheter could be crushed.
Guidewire Positioning
1. Position an access wire across the aneurysm neck using standard microcatheter and guidewire
techniques. Recommended guiding catheter specifications include 90 cm length and minimum inner
diameter of 1.27 mm (0.050 in).
2. Replace the access guidewire with an exchange length 0.36 mm (0.014 in) guidewire, and remove the
microcatheter. Leave the exchange guidewire across the aneurysm neck. Soft guidewires are recommended
rather than support guidewires.
Stent Positioning and Deployment
1. Carefully backload the 3F Microdelivery Catheter onto the 0.36 mm (0.014 in) guidewire. Ensure that the
guidewire does not push the Peelable Sheath inside the tip of the 3F Microdelivery Catheter.
2. Once a sufficient length of the guidewire is inside the 3F Microdelivery Catheter and through the 2F Stabilizer
Catheter, carefully slide the Peelable Sheath out of the 3F Microdelivery Catheter and along the guidewire.
Care should be taken to ensure the Stent does not move. If necessary, slight pressure on the 3F Microdelivery
Catheter in the area of the Stent will ensure the Stent does not move.
3. Remove the Peelable Sheath from the guidewire and 3F Microdelivery Catheter by tightly gripping both ends of
the Peelable Sheath and slide the ends toward the center of the Peelable Sheath. This will cause the Peelable
Sheath to buckle in the center. Carefully grasp the buckled center of the Peelable Sheath and remove it from the
guidewire. Ensure that the entire Peelable Sheath is removed from the guidewire.
4. Carefully advance the Neuroform Microdelivery Stent System as one unit into the guiding catheter.
5. Adjust the hemostasis valve on the 3F Microdelivery Catheter to hold the 2F Stabilizer Catheter in place during
advancement of the Neuroform Microdelivery Stent System. Do not overtighten the hemostasis valve because
the 2F Stabilizer Catheter could be crushed.
2
• Stent migration/embolization
• Stent Fracture
• Stent misplacement
• Stent thrombosis
• Stroke
• Transient ischemic attack
• Vasospasm
• Vessel occlusion or closure
• Vessel thrombosis
• Vessel perforation/rupture, dissection, trauma or damage