Surpass Streamline; Flow Diverter - Stryker Surpass Streamline Gebrauchsanweisung

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 System. The Surpass Streamline Flow Diverter system consists
of the following components:
• Surpass™ Flow Diverter (implant)
• Delivery System
• Surpass Streamline outer
• Surpass Streamline pusher
The Surpass Flow Diverter is preloaded onto the Surpass Streamline pusher which in turn
is locked in place within the Delivery System 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 System. 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 System 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.
Surpass Streamline outer
The Delivery System 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 Surpass Streamline outer. The distal section
of the Surpass Streamline outer has a hydrophilic coating to improve device tracking in
tortuous vessels.
Surpass Streamline pusher
The Surpass Streamline pusher is a second catheter that resides within the Surpass
Streamline outer. It pushes the Surpass Flow Diverter out of the Surpass Streamline outer
into the parent artery across the aneurysm neck and stabilizes the position of Surpass Flow
Diverter within the Surpass Streamline outer.
A radiopaque marker at the formed tip (Tip marker) marks the tip of the Surpass Streamline
pusher.
Black (K) ∆E ≤5.0
™
There is another marker band called the proximal Surpass Streamline pusher marker. The
Surpass Flow Diverter is loaded between the proximal Surpass Streamline 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
SURpASS STREAmLINE
Y-VALVE
pUSHER
DETAIL A
pROXImAL SURpASS STREAmLINE
pUSHER mARKER
AppROXImATELY 10 mm
The Surpass Streamline Flow Diverter system is designed for use under fluoroscopy.
INTENDED USE/INDICATIONS FOR USE
The Surpass Streamline 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.
2
135 cm
SURpASS STREAmLINE OUTER
3.9F (1.30mm) 3.7F (1.25mm)
SEE DETAIL A
DISTAL TIp OF SURpASS
FLOW DIVERTER
STREAmLINE OUTER
RECApTURE
FEATURE
AppROXImATELY 10 mm
SURpASS STREAmLINE
pUSHER TIp mARKER