Adverse Events - Stryker Surpass Evolve Mode D'emploi

• 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 stenosis; and/or
• Intracranial vasospasm not responsive to medical therapy.
warnInGs
• This device should only be used with adequate fluoroscopic guidance
by physicians who have received appropriate training in interventional
neuroradiology or interventional radiology, and training on the use of this
device as established by Stryker Neurovascular.
• Persons allergic to nickel, cobalt chromium or platinum tungsten metal may
suffer an allergic response to this system.
• 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.
• Replace the system if any defects are observed during use.
• Purge the entire system carefully to avoid the accidental introduction of air
into the patient.
• At any time during the procedure discontinue use of the system if excessive
resistance is encountered. Movement of the system against resistance may
result in damage to the vessel, a system component, or the patient.
• Do not resheath the implant into the introducer sheath once transferred into
the microcatheter as it may result in damage to the implant wires.
• It is important for the Surpass Evolve™ Flow Diverter System to be used with
the Stryker Neurovascular Excelsior
with a 135cm length (Model UPN M003XT2735810) or 150cm length (Model
UPN M003XT2750810).
• Repositioning of the Surpass Evolve Flow Diverter in the parent vessel without
fully retrieving the device is not advised since it could cause vessel damage
and/or perforation. After full deployment, do not re-position.
• [Clinical Warning] Do not use Surpass Evolve Flow Diverter for ruptured
intracranial aneurysms.
• [Clinical Warning] A decrease in effectiveness has been observed in subjects
aged > 65 years old, subjects with history of smoking and history of prior
non-target intracranial aneurysm treated.
• [Clinical Warning] Judicious patient selection is important. Patients who fall
outside the therapeutic range for antiplatelet testing or at the lower limits
of platelet inhibition have an increased risk of developing stent thrombosis,
even with additional doses of antiplatelet medication. Another effective anti-
platelet agent should be considered.
• [Clinical Warning] Placement of multiple Surpass Evolve Flow Diverters may
increase the risk of ischemic complications.
• [Clinical Warning] Delayed aneurysm rupture may occur with large and giant
intracranial aneurysms.
XT-27 Standard Straight Microcatheter
® ®
precaUtIons
• This device has not been evaluated for pediatric use.
• The safety and effectiveness of the device has not been established in the
treatment of small and medium wide-neck intracranial aneurysms.
• Experience with endovascular 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.
• Select a device length that is at least 10mm longer than the intracranial
aneurysm neck to maintain a minimum of 5mm on either side of intracranial
aneurysm neck. Confirm the device labeling reflects the desired size of the
target vessel where the device is to be used.
• Use care when removing the device from its hoopcard so as not to eject the
implant from the introducer sheath.
• Do not expose the system to organic solvents (e.g., alcohol) as it may result in
damage to the system.
• Do not torque or rotate the delivery wire as it may result in system damage.
• Do not attempt to partially deploy and recapture the implant more than three
times as it may result in a loss of system performance.
• Use care when crossing the deployed implant with guidewires or other
accessory devices as it may cause the implant to migrate distally.
• Operators should take all necessary precautions to limit X-radiation dose to
patients and themselves by using sufficient shielding, reducing fluoroscopy
times, and modifying X-ray technical factors where possible.
• Lower intracranial aneurysm occlusion rates may be associated with giant
intracranial aneurysms (>25mm).
• Lower intracranial aneurysm occlusion rates may be associated with implants
that are not fully apposed to the vessel wall.
• Do not deploy Surpass Evolve Flow Diverters in parallel (side by side).

aDverse events

Risks that may be associated with the use of the Surpass Evolve Flow Diverter
System in the intracranial arteries include:
• Adverse reaction to anesthesia, contrast or antiplatelet/anticoagulation agents
• Allergic reaction
• Aphasia
• Cardiac Arrhythmia
• Confusion, coma, change in mental status
• Cranial neuropathy/neurological deficits
• Death
• Device migration, fracture, misplacement
• Dissection of the parent artery
• Embolism (air, clots, device fragments)
• Groin injury (bleeding, pain, vessel/nerve damage)
• Headache
• Hemiplegia
• Hydrocephalus
• Implant or parent vessel stenosis
• Implant thrombosis/occlusion
• Infection
• Intracerebral bleeding
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Black (K) ∆E ≤5.0