Directions For Use; How Supplied - Stryker Surpass Streamline Mode D'emploi

ADVERSE EVENTS
Risks that may be associated with the use of the Surpass™ Flow Diverter in the intracranial
arteries include:
• Aneurysm recanalization
• Aneurysm enlargement
• Allergic reaction, including, but not limited to,
an allergic reaction to contrast, nickel, cobalt
chromium or platinum tungsten metal, and
medications
• Arrhythmia
• Arteriovenous fistula
• Confusion, coma, loss of consciousness or
other change in mental status
• Death
• Detachment of a component of the system
• emboli (air, tissue or thrombotic emboli)
• emergent neurosurgery
• Failure to deliver the device to the intended site
• headache
• hemorrhage (including intracranial, vascular,
peritoneal, and groin)
• hematoma
• hypotension / hypertension
• hydrocephalous
• Incomplete Aneurysm Occlusion
• Infection
• Injury to normal vessels or tissue
Please notify your Stryker Neurovascular representative immediately if a device malfunctions or
patient complication or injury is experienced or suspected. Please make every attempt to retain any
suspect device, its associated components and their packaging for return to Stryker Neurovascular.
MAGNETIC RESONANCE IMAGING (MRI) INFORMATION
The Surpass Flow Diverter was determined to be Mr Conditional.
Non-clinical testing demonstrated that the Surpass Flow Diverter is Mr Conditional. A patient with
this device can be scanned safely immediately after placement under the following conditions:
Static Magnetic Field
• Static magnetic field of 3-Tesla or less
• Maximum spatial gradient magnetic field of 2,000-Gauss/cm or less*
• Mr system operating in the First Level Controlled Mode (i.e., the mode of operation of the
Mr system in which one or more outputs reach a value that may cause physiological stress to
patients which needs to be controlled by medical supervision) at a whole body averaged SAR
of 4.0-W/kg for 15 min. of scanning (i.e., per pulse sequence)
*Translational Attraction
The measured value of the highest spatial gradient used for the assessment of translational
attraction for the Surpass Flow Diverter implant was 720-Gauss/cm. The calculated acceptable
level for the spatial gradient magnetic field was based on consideration of this value along with
the magnetic field strength at this position, the measured deflection angle for this implant, and
includes a margin of safety.
MRI-Related Heating
In non-clinical testing, the Surpass Flow Diverter produced the following temperature rise during
MrI performed for 15-min of scanning (i.e., per pulse sequence) in the 3-Tesla (3-Tesla/128-Mhz,
excite, hDx, Software 14X.M5, General electric healthcare, Milwaukee, WI) Mr system:
Highest temperature Change + 2.3°C
Therefore, the MrI-related heating experiments for the Surpass Flow Diverter at 3-Tesla using a
transmit/receive rF body coil at an Mr system reported whole body averaged SAr of 2.9 -W/kg
(i.e., associated with a calorimetry measured whole body averaged value of 2.7-W/kg) indicated
that the greatest amount of heating that occurred in association with these specific conditions was
equal to or less than +2.3°C. This value scaled is 3.4°C when scaled to a whole body averaged SAR
of 4.0-W/kg.
Artifact Information
Mr image quality may be compromised if the area of interest is in the exact same area or relatively
close to the position of the Surpass Flow Diverter. Therefore, optimization of Mr imaging parameters
to compensate for the presence of this device may be necessary. The maximum artifact size (i.e., as
seen on the gradient echo pulse sequence) extends approximately 10-mm relative to the size and
shape of the Surpass Flow Diverter.
Pulse Sequence T1-SE T1-SE
Signal Void Size 544-mm 82-mm
2
Plane Orientation Parallel Perpendicular
Overlapping Stents
The effect of heating in the MrI environment for overlapping stents is not known.

HOW SUPPLIED

Stryker Neurovascular products are sterile and non-pyrogenic in unopened packaging that is
designed to maintain sterility unless the primary product pouch has been opened or damaged.
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.
• Ischemia
• Occlusion of side branch
• Mass effect
• Myocardial infarction
• Nausea
• Neurologic deficit
• Pain at insertion site
• Perforation of aneurysm
• Pseudoaneurysm
• reactions due to radiation exposure
• renal failure
• rupture, vessel or aneurysm
• Seizures
• Stenosis of treated segment
• Device migration / embolization
• Device thrombosis / occlusion
• Stroke /TIA/ cerebrovascular accident –
new or worsening of symptoms
• Total occlusion of treated segment
• Vasospasm
• Vessel dissection or perforation
• Vessel thrombosis/occlusion
• Visual impairment/blindness
• Vomiting
Gre Gre
1,104-mm 220-mm
2 2 2
Parallel Perpendicular
PREPARATIONS FOR USE
In addition to the Surpass Flow Diverter the following items are recommended:
• 6F (2.00 mm) or greater Introducer Sheath, appropriately sized
• 0.014 in (0.36 mm) access and/or exchange length Guidewire
• 0.053 in (1.35 mm) ID minimum Guiding Catheter/Intermediate Catheter, max 115 cm long
• 2 or more y connectors / rotating hemostasis Valves
• Sterile heparinized saline solution
Surpass Flow Diverter Selection
Appropriate selection of the device is important for patient safety. In order to choose the optimal
device for any given aneurysm neck length and parent artery diameter, examine pre-procedure
angiograms.

DIRECTIONS FOR USE

Flow Diverter Selection and Preparation
1. Choose a Surpass Flow Diverter with a labeled diameter that approximates the target vessel
diameter (see Table 1).
Table 1. Device Sizes
Unconstrained
Device Diameter and
Implant OD
Lengths (mm)
(mm)
3 x 15, 20, 25 > 3.5
4 x 15, 20, 25, 30, 40, 50 > 4.4
5 x 20, 25, 30, 40, 50 > 5.3
2. Choose a Surpass Flow Diverter with a labeled length that is at least 10 mm longer than the
aneurysm neck (to maintain a minimum of 5 mm on either side of the neck) and allows for the
proximal and distal ends of the Surpass Flow Diverter to land in a straight section of the vessel.
Note: The Surpass Flow Diverter changes in length during deployment. Take this into account
when deploying (Table 2). The Surpass Flow Diverter deployed length will never be shorter than
its labeled length, even after foreshortening.
Table 2. Device Deployed Length Changes
Average decrease in length from inside delivery catheter to
Device Diameter (mm)
3
4
5
3. Remove the Delivery System from its packaging and inspect the entire system prior to use. Do
not use the Surpass Flow Diverter if the packaging and/or any component appears damaged or
missing.
Caution: Carefully remove the tray lid and grasp the Delivery System by its RHV and hoop to
facilitate removal from the tray.
4. Flush the dispenser hoop with sterile heparinized saline. Purge the Delivery Catheter and
Pusher with sterile heparinized saline.
Warning: Purge the entire Delivery System carefully to avoid the accidental introduction of air
into the system.
5. Confirm that no more than 3 mm of the Pusher tip extends from the tip of the Delivery Catheter.
Note: If the Pusher tip extends too far from the Delivery Catheter, trackability of the system may
be impaired.
6. Tighten the rhV on the Delivery Catheter to hold the Pusher in place.
Flow Diverter Positioning (Exchange technique)
1. Use standard catheter and guidewire access techniques to position an intermediate catheter
with an ID of no less than 0.053 in proximal to, or if needed, distal to the aneurysm neck.
2. Carefully backload the Delivery Catheter onto the 0.014 in exchange length guidewire used in
step 1.
3. Under fluoroscopic guidance, carefully advance the Delivery Catheter over the guidewire and
through the intermediate catheter until the Delivery Catheter is past the aneurysm location.
4. If needed, pull the intermediate catheter back while keeping the Delivery Catheter in place
across the neck of the aneurysm.
5. Confirm the position of the Delivery Catheter by visualizing the radiopaque markers. Make sure
that the distal marker on the Delivery Catheter is at least 5 mm past the neck of the aneurysm.
Note: Pulling back on the Delivery Catheter to make final adjustments will ensure that slack has
been removed from the Delivery Catheter prior to deployment.
6. The Surpass Flow Diverter is now ready to be deployed.
Flow Diverter Positioning (Direct technique)
1. Use standard catheter and guidewire access techniques to position an intermediate catheter with
an ID of no less than 0.053 in proximal to, or if needed, distal to the aneurysm neck.
2. Remove the wire used in step 1, leaving the catheter in position.
3
Maximum vessel Recommended
diameter minimum vessel
(mm) diameter (mm)
3.5 2.5
4.4 3.4
5.3 4.3
fully expanded (%)
38
42
29
Black (K) ∆E ≤5.0