English - ev3 Artisse Instrucciones De Uso

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Instructions for Use
Artisse™ Intrasaccular Device
DEVICE DESCRIPTION
The Artisse™ intrasaccular device system [Figures 1a, 1b and 1c] is a self-expanding drawn-
filled radiopaque nickel titanium, double-layer wire braid, compliant, closed-cell design that
can be deployed and retrieved by a single operator . Proximal and distal ends of the implant
are secured and marked with two radiopaque platinum-iridium alloy markers .
The implant is available in two configurations: (Spheroid and Flared) . The implant is mounted
on a Nitinol pusher-wire approximately 185 cm long . Implant location for detachment is
assessed utilizing the implant radiopaque markers . An introducer sheath is packaged with
each Artisse™ intrassacular device and is designed to protect the distal portion of the implant,
while the Artisse™ intrasaccular device is prepped, loaded and advanced through the delivery
microcatheter . Implant is detached via a portable, handheld electrolytic detachment device .
Distal Marker
Radiopaque
DFT Strands
Proximal Marker
Spheroid Shape
Figure 1a: The Artisse™ Intrasaccular Device Shapes
Fluorosafe Marker
Fully Visualized Radiopaque Distal
Electrolytic
Implant Pusher (30 mm)
Detachment Zone
Figure 1b: The Artisse™ Intrasaccular Device Implant Delivery System
Figure 1c: The Artisse™ Detachment Device (ADD)
The Artisse™ intrasaccular device's nitinol delivery wire system is designed for distal
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navigation through a maximum 150 cm length, compatible 0 . 0 21 inch (0 . 5 3 mm) inner
diameter delivery microcatheter for 4 . 5 mm to 8 mm implant diameter sizes . The Artisse™
intrasaccular device can be fully deployed and recaptured from the delivery microcatheter
up to 3 times .
Implant location for detachment is assessed utilizing the fully visualized implant as well as
the distal and proximal markers . The Artisse™ implant is detached via a portable, handheld
electrolytic detachment device (Artisse™ detachment device, Figure 1c) . The Artisse™
intrasaccular device unconstrained implant size is shown on the product label .
INDICATIONS FOR USE
The Artisse™ intrasaccular device is intended for the endovascular embolization of saccular
intracranial aneurysms .
CONTRAINDICATIONS
• Patients with active bacterial infection .
WARNING
• The Artisse™ intrasaccular device should be used only by physicians trained in
percutaneous, intrasaccular techniques and procedures at medical facilities with
the appropriate fluoroscopic equipment .
• For single use only . Do not reprocess or resterilize . Reprocessing and resterilization
increase the risk of patient infection and compromised device performance .
• Carefully inspect the sterile package and device components prior to use to verify
that they have not been damaged during shipping . Do not use kinked or damaged
components .
• To minimize the potential risk of emboli, do not allow an inappropriately sized
or positioned implant to reside in the aneurysm beyond the activated clotting
Flared Shape
time (ACT) .
• Only use one Artisse™ intrasaccular device per aneurysm .
• Do not use the Artisse™ intrasaccular device in patients in whom angiography
demonstrates inappropriate anatomy, such as severe vessel tortuosity or
nonsaccular, amorphically shaped aneurysms which may not permit proper
deployment or detachment of the device in an aneurysm .
• Assess proper placement and size of the implant, optimal compliance to the
walls within the aneurysm and coverage across the neck of the aneurysm before
making preparations to detach the implant .
• Do not use a device implant with a smaller labeled width than the measured
average width of an aneurysm .
• Recapturing the Artisse™ intrasaccular device more than 3 full cycles within a
microcatheter may cause damage to the distal or proximal ends of the braid .
• Persons with known allergy to metal, such as platinum, nickel-titanium (including
the major elements platinum, nickel, molybdenum or tungsten) or cobalt/
chromium alloy (including the major elements platinum, cobalt, chromium,
Delivery
nickel, molybdenum or tungsten) may suffer an allergic reaction to the Artisse™
Microcatheter
intrasaccular device or Artisse™ intrasaccular device delivery system .
POTENTIAL COMPLICATIONS
Potential complications include, but are not limited to:
• Arrhythmia
• Cerebral Infarction
• Death
• Dissection
• Dissection, Intimal
• Embolism
• Fever
• Fistula
• Foreign Body Reaction
• Hematoma
Fluoroscopic
• Hemolysis
Image Highlighting
• Hemorrhage, Intracranial
the Electrolytic
• Hypertension
Detachment
• Hypotension
• Infection
PRECAUTIONS
• Do not use product if sterile package is damaged .
• Use the Artisse™ intrasaccular device prior to the "Use By" date printed on the package .
• The appropriate anti-platelet and anti-coagulation therapy should be administered in
accordance with standard medical practice .
• Do not attempt to place the Artisse™ intrasaccular device in patients in whom an
obstruction, such as pre-existing stent is in place in the parent artery at the target
aneurysm location .
• A thrombosed aneurysm may aggravate pre-existing, or cause new symptoms of mass
effect and may require medical therapy .
• Failure to remove the introducer sheath after inserting the delivery wire into the RHV
of the microcatheter will interrupt normal infusion of flush solution and allow back
flow of blood into the microcatheter .
• Advance and retract the Artisse™ intrasaccular device carefully and smoothly without
excessive force . If unusual friction is noticed, slowly withdraw the device and examine
for damage . If damage is present, remove and use a new device . If friction or resistance
• Inflammation
• Necrosis
• Nerve Damage
• Neurological Deficit/Dysfunction
• Organ Failure
• Pain
• Radiation Exposure, Unintended, Major
• Shock
• Stenosis
• Therapeutic Response Decreased
• Thrombosis
• Toxicity
• Transient Ischemic Attack
• Vasoconstriction
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is still noted, carefully remove the Artisse™ intrasaccular device and microcatheter and
examine the microcatheter for damage .
• Increased detachment times may occur when:
o Thrombus is present on the electrolytic detachment zone .
o Insufficient heparinized saline flush .
• Do not use detachment devices other than the Artisse™ detachment device (ADD) .
• It is recommended to have at least one extra Artisse™ detachment device (ADD) as a
backup detachment device .
• Do not attempt to reposition the Artisse™ intrasaccular device implant after
detachment with the ADD .
COMPATIBILITY
Refer to product label for device size code . The Artisse™ intrasaccular device 4 . 5 mm through
8 mm sizes are designed to be delivered through a compatible 0 . 0 21" (0 . 5 3 mm) inside
diameter microcatheter .
MAGNETIC RESONANCE IMAGING
Non-clinical testing demonstrated that the Artisse™ intrasaccular device is MR Conditional . A
patient with this device can be scanned safely in an MR system immediately after placement
under the following conditions:
• Static magnetic field of 1 . 5 -Tesla and 3-Tesla only
• Maximum spatial gradient magnetic field of 3000 Gauss/cm or less
• Maximum MR system reported, whole body averaged specific absorption rate (SAR)
of 2-W/kg for 15 minutes of scanning in the Normal Operating Mode of operation for
the MR System
• Under the scan conditions defined, the Artisse™ intrasaccular device is expected
to produce a maximum temperature rise of 1 . 5 ° C after 15-minutes of continuous
scanning .
ARTIFACT INFORMATION
In non-clinical testing, the image artifact caused by the Artisse™ intrasaccular device extends
approximately 2 mm from this implant using a gradient echo pulse sequence and a 3-Tesla
MR system .
DIRECTIONS FOR USE
1. Aneurysm Sizing and Device Selection:
A . Perform fluoroscopic road mapping .
B . After ensuring proper calibration between 3D and fluoroscopic imaging,
perform an angiogram (to include lateral/orthogonal imaging) to properly
measure and determine the maximum and average width (W), height (H) and
neck (N) of the aneurysm [Figure 2] .
Figure 2: Measuring Aneurysm Width (Dome), Height and Neck
C . Refer to the Artisse™ intrasaccular device reference tables for recommended
sizing options [Tables 1a (Spheroid Shape) and 1b (Flared Shape)]:
1 . Based on the measurements and morphology, determine whether a
Spheroid or Flared Implant Shape is desired . The product label shows the
implant shape as well as the unconstrained implant width (W) and height
(H) .
2 . Ensure that the labeled implant width size is equal to or greater than the
measured average aneurysm width (dome) for implant compression and
stability . Upsize implant size as needed .
3 . After determining the desired implant shape and size, ensure that implant
height enables appropriate neck coverage .
CAUTION
Use all means available to reliably and predictably assess the final height of a properly
placed, slightly compressed and constrained implant within an aneurysm vs . the measured
aneurysm height .
2. Access and Catheterization:
A . Using standard interventional radiographic technique, access the vessel and
aneurysm using a triaxial system, guidewire and the appropriate 0 . 0 21" inner
diameter delivery microcatheter .
WARNING
• In order to achieve optimal performance of the Artisse™ intrasaccular device and
to reduce the risk of thromboembolic complications, it is critical that a continuous
infusion of appropriate heparinized saline flush solution be maintained between
a) the femoral sheath and guiding catheter, b) the delivery microcatheter and
guiding catheters and c) the delivery microcatheter, guidewire and delivery
wire . Continuous flush also reduces the potential for thrombus formation on,
and crystallization of infusate around, the detachment zone of the Artisse™
intrasaccular device .