Surpass™ Streamline; Flow Diverter - Stryker Surpass Streamline Mode D'emploi

Surpass™ Streamline™

Flow Diverter

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.
DEVICE DESCRIPTION
The Surpass Streamline Flow Diverter system is comprised of a self-expandable braided device
preloaded in a Delivery Catheter. The Surpass Streamline Flow Diverter system consists of the
following components:
• Surpass Flow Diverter
• Delivery Catheter
• Pusher
The Surpass Flow Diverter is preloaded onto the Pusher which in turn is locked in place within the
Delivery Catheter via a Y-Valve/Rotating Hemostatic Valve (RHV). Each device is shipped sterile and
labeled for single use only.
Surpass Flow Diverter
The braided Surpass Flow Diverter is the implant portion of the system. It is shipped pre-loaded within
the Delivery Catheter. These devices come in different sizes and length combinations ranging from
3 mm to 5 mm in diameter and from 15 mm to 50 mm in length. Interwoven within the Surpass Flow
Diverter cobalt chromium braids are platinum-tungsten wires for visualization under fluoroscopy.
Once released from the constraint of the Delivery Catheter into the vessel, the Flow Diverter expands
to the vessel lumen diameter. In its expanded shape, the Surpass Flow Diverter diverts the blood flow
away from the aneurysm.
Delivery Catheter
The Delivery Catheter functions to house and protect the Surpass Flow Diverter during its passage
through the arterial system and across the aneurysm neck. There is a single radiopaque marker
located at the distal tip of this Delivery Catheter. The distal section of the Delivery Catheter has a
hydrophilic coating to improve device tracking in tortuous vessels.
Pusher
The Pusher is a second catheter that resides within the Delivery Catheter. It pushes the Surpass
Flow Diverter out of the Delivery Catheter into the parent artery across the aneurysm neck and
stabilizes the position of Surpass Flow Diverter within the Delivery Catheter.
A radiopaque marker at the formed tip (Tip marker) marks the tip of the Pusher.
There is another marker band called the proximal Pusher marker. The Surpass Flow Diverter is
loaded between the proximal Pusher marker and the tip marker. The length of this section varies
such that the different sizes of the Surpass Flow Diverter fit between the two marker bands.
DELIVERY SYSTEM
PuSher
Y-VALVE
3.9F (1.30mm)
DETAIL A
PrOXIMAL PuSher MArKer FLOW
DIVERTER
reCAPTure FeATure
APPrOXIMATeLy 10 mm
The Surpass Streamline Flow Diverter system is designed for use under fluoroscopy.
Black (K) ∆E ≤5.0
135 cm
DELIVERY CATHETER
3.7F (1.25mm)
SEE DETAIL A
DELIVERY DISTAL TIP OF
PuSher TIP
CATHETER DELIVERY CATHETER
MArKer
APPrOXIMATeLy 10 mm
INTENDED USE/INDICATIONS FOR USE
The Surpass Flow Diverter is indicated for use for the treatment of saccular or fusiform intracranial
aneurysms arising from a parent vessel with a diameter of ≥2.5 mm and ≤5.3 mm.
CONTRAINDICATIONS
Intracranial artery stenting is generally contraindicated in the following patient types:
• Patients in whom the parent vessel size does not fall within the indicated range.
• Patients in whom antiplatelet and / or anticoagulation therapy (e.g., aspirin and clopidogrel)
is contraindicated.
• Patients who have not received dual anti-platelet agents prior to the procedure.
• Patients with an active bacterial infection.
• Patients in whom the angiography demonstrates the anatomy is not appropriate for
endovascular treatment, due to conditions such as:
- Severe intracranial vessel tortuosity or stenoses
- Intracranial vasospasm not responsive to medical therapy
WARNINGS
• The procedure should be carried out under the direction of personnel with the requisite
interventional training, especially intracranial stent procedures. Appropriate facilities should be
available for managing the potential complications of the procedure.
• Complications may occur without warning. At all times a fully equipped emergency cart and
resuscitation equipment should be readily available, and personnel competent in recognizing and
treating complications of any severity should be on hand.
• Do not use if the package is opened or damaged.
• Persons allergic to nickel, cobalt chromium or platinum tungsten metal may suffer an allergic
response to this Flow Diverter implant.
• The system is designed to be manipulated while under high-quality fluoroscopic observation.
If resistance is met during manipulation, determine the cause of resistance before proceeding.
• Do not torque or rotate the System.
• Purge the entire Delivery System carefully to avoid the accidental introduction of air into the
system.
• If any defects are observed with the Surpass Streamline Flow Diverter system, replace the device.
• If excessive resistance is encountered during the use of the Surpass Flow Diverter at any time
during the procedure, discontinue use of the System. Movement of the System against resistance
may result in damage to the vessel, a System component, or the patient.
PRECAUTIONS
• experience with device implants indicates that there is a risk of stenosis. Subsequent stenosis
may require dilatation of the vessel segment containing the device. The risks and long-term
outcome following dilatation of endothelialized devices is unknown at present.
• Confirm the device labeling reflects the desired size of the target vessel where the device is to
be used.
• Do not expose the system to organic solvents (e.g., alcohol).
• Appropriate anti-platelet and anti-coagulation therapy should be employed in accordance with
standard medical practice.
• A thrombosing aneurysm may aggravate pre-existing or cause new symptoms of mass effect
and may require medical therapy.
• use product prior to the "use By" date.
• The ability of the device to withstand balloon post-dilatation has not been established.
• Do not remove the Surpass Flow Diverter from its Delivery Catheter. The device and delivery
catheter are intended to perform as a single system and must not be altered.
• Carefully inspect the device packaging and system prior to use. Do not use the Surpass Flow
Diverter if any component appears damaged or missing.
• Carefully remove the tray lid and grasp the Delivery System by its rhV and hoop to facilitate
removal from the tray.
• Select a device length that is at least 10 mm longer than the aneurysm neck to maintain a
minimum of 5 mm on either side of aneurysm neck.
• Do not attempt to partially deploy and recapture the Surpass Flow Diverter more than three times.
• use caution when crossing the deployed device with guidewires or other accessory devices.
• Dispose of all used devices in accordance with hospital policy for biohazardous materials.
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