Endeavor Resolute Zotarolimus-Eluting Coronary Stent System - Medtronic Endeavor Resolute Produktbeschreibung

the balloon as it may cause uneven expansion and
difficulty in deployment of the stent.
6.2 STENT PLACEMENT – PRECAUTIONS
• Do not prepare or pre-inflate the stent delivery
system prior to stent deployment, other than as
directed. Use balloon-purging technique described in
Section 9.3 PREPARATION OF DELIVERY SYSTEM.
• If additional stenting is required, stent materials of
similar composition should be used.
• Implanting a stent may lead to dissection of
the vessel distal and/or proximal to the stented
portion, and may cause acute closure of the vessel
requiring additional intervention (e.g., CABG, further
dilatation, or placement of additional stents).
• Do not expand the stent if it is not properly
positioned in the vessel (See Section 9.7 STENT /
DELIVERY SYSTEM REMOVAL PRECAUTIONS).
• The long-term outcome following repeat dilatation
of endothelialized coronary stents is unknown at
present.
• Placement of the stent has the potential to
compromise side branch patency
• Do not exceed Rated Burst Pressure as
indicated on product label. Balloon pressures
should be monitored during inflation. Use of
pressures higher than those specified on product
label may result in a ruptured balloon and potential
intimal damage and dissection (See Table 2).
• Stent retrieval methods (use of additional wires,
snares and/or forceps) may result in additional
trauma to the coronary vasculature and/or the
vascular access site. Complications can include
bleeding, hematoma or pseudoaneurysm.
6.3 POST-IMPLANT– PRECAUTIONS
Care must be exercised when crossing a newly deployed
stent with an intravascular ultrasound (IVUS) catheter, a
coronary guidewire, or a balloon catheter or any other device to
avoid disrupting the stent placement, apposition, coating and/or
the stent geometry of the Endeavor Resolute Stent.
Non-clinical magnetically induced deflection and torque
testing at 3 Tesla, maximum spatial gradient of 525 gauss/cm
(5.25 Tesla/meter) indicates that the Endeavor Resolute Stent
should not move or migrate immediately post-implantation.
The Endeavor Resolute Stent produces a temperature rise
of less than 0.5 degrees C in association with MR imaging
performed at a whole body averaged specific absorption
rate (SAR) of 2.0 W/kg, spatial peak SAR of 4.0 W/kg for
20 minutes. The effect of performing MRI procedures using
higher levels of RF energy on a patient with the Endeavor
Resolute Stent has not been determined. The results may
not apply to overlapping stents. The effect of heating in
association with MRI on the drug or polymer coating is
unknown.
MR image quality may be compromised if the area of interest
lies close to or is in the same position as the stent.
Post-dilatation: All efforts should be made to assure that
the stent is not underdilated. If the deployed stent is not
fully apposed to the vessel wall, the stent may be expanded
further with a larger diameter balloon that is slightly shorter
(about 2 mm) than the stent. The post-dilatation can be done
using a low-profile, high pressure, and non-compliant balloon
catheter and the balloon should not extend outside of the
stented region. The Endeavor Resolute Stents should not
be expanded to a diameter beyond 0.5 mm of its nominal
expansion.
7.0 POTENTIAL ADVERSE EFFECTS
The following complications may be associated with the
use of coronary stenting devices, IVUS, or PTCA (listed
in order of severity):
• Death
• Aneurysm, pseudoaneurysm, or arteriovenous
2
fistula (AVF)
• Stent deformation, collapse, or fracture
• Emergency surgery: peripheral vascular or
coronary bypass
• Stroke / transient ischemic attack
• Cardiac tamponade
• Coronary artery occlusion, perforation, rupture,
or dissection
• Pericarditis
• Embolism (air, tissue, device, or thrombus)
• Thrombosis (acute, subacute, or late)
• Incomplete stent apposition
• Myocardial infarction (MI)
• Restenosis of the stented artery
• Arrhythmias
• Hemorrhage requiring transfusion
• Shock / pulmonary edema
• Coronary artery spasm
• Abrupt vessel closure
• Hypotension / hypertension
• Allergic reaction (to contrast, antiplatelet
therapy, stent system- material, drug or
polymer coating)
• Peripheral ischemia / peripheral nerve injury
• Infection or fever
• Unstable angina
• Access site pain, hematoma or hemorrhage
• Balloon rupture
• Stent migration
• Failure to deliver the stent
• Stent misplacement
The occurrence of the above listed complications
may lead to the need for a repeat catheterization
and/or percutaneous coronary intervention, myocardial
infarction, emergency bypass surgery, or death. The
following additional side effects/complications may be
associated with but not limited to the use of zotarolimus
(listed in alphabetical order):
• Anemia
• Circumoral paresthesia
• Diarrhea
• Dry Skin
• Headache
• Hematuria
• Infection
• Pain (abdominal or arthralgia)
• Rash
The side effects/complications of the BioLinx polymer are
no different than those of other stent coatings and may
include but are not limited to the following:
• Focal inflammation at the site of stent
implantation
• Restenosis of the stented artery
• Allergic reaction
8.0 PATIENT SELECTION AND TREATMENT
The risks and benefits described above should be
carefully considered for each patient before use of the
Endeavor Resolute Zotarolimus-Eluting Coronary Stent
System.
The safety and effectiveness of using mechanical
atherectomy devices (directional atherectomy catheters,
rotational atherectomy catheters), or laser angioplasty
catheters, to treat in-stent stenosis have not been
established.
9.0 CLINICIAN USE INFORMATION
9.1 INSPECTION PRIOR TO USE
Carefully inspect the sterile package before opening. Do
not use if the package has been damaged or opened.
Do not use the product after the "Use By" date.
The outer pouch contains two small packets (one used to
remove oxygen from the pouch and one used to remove
moisture). Please discard these packets after opening
the pouch. Note that the exterior surface of the inner
pouch is not sterile.
If the sterile package appears intact, carefully remove the
system from the package and inspect for bends, kinks
and other damage. Do not use if any defects are noted.
9.2 MATERIALS REQUIRED
• 1.42 mm (5 Fr / 0.056") minimum inner
diameter guide catheter
• 20 cc syringe
• Heparinized normal saline
• 0.36 mm (0.014") maximum outer diameter
guidewire
• Rotating hemostatic valve
• Contrast medium diluted 1:1 with heparinized
normal saline
• Inflation device
• Torque device
• Three-way stopcock
9.3 PREPARATION OF DELIVERY SYSTEM
1. Prepare the guide catheter and guidewire
according to the manufacturer's instructions.
The Endeavor Resolute Stent is compatible
with 0.36 mm (0.014") guidewires. Refer to
product labeling or Section 9.2 MATERIALS
REQUIRED for specific guide catheter
compatibility.
2. Careful stent sizing is important to successful
stenting. Select stent length appropriate for
the target lesion (≥ 3 mm longer than the
lesion length). Ensure the selected stent is
long enough to cover the lesion completely.
Note: The inflated balloon diameter measures
slightly larger than the labeled stent inner
diameter to allow for stent recoil following
expansion (see Table 3).
3. Remove the stent delivery system from the
package.
4. Remove the protective sheath and stylet by
carefully placing the thumb and forefinger on
the tapered end of sheath. DO NOT touch the
part of the sheath over the stent.
5. Inspect the stent to ensure it has not been
damaged or displaced from its original
position on the balloon. Verify that the stent
is positioned between the proximal and distal
balloon markers.
Note: Should there be movement of or damage to
the stent, do not use.
6. Flush Stent Delivery System guidewire lumen
with heparinized normal saline until fluid exits
the distal tip.
7. Fill a 20 cc syringe with 5 cc of contrast/
heparinized normal saline mixture (1:1).
8. Attach to delivery system and apply negative
pressure for 20-30 seconds.
9. Slowly release pressure to allow negative
pressure to draw mixture into balloon lumen.
10. Detach syringe and leave a meniscus of
mixture on the hub of the balloon lumen.
11. Prepare inflation device in standard manner
and purge to remove all air from syringe and
tubing.
12. Attach inflation device to catheter directly
ensuring no bubbles remain at connection.
13. Leave on ambient pressure (neutral position).
Note: Do not apply negative pressure on inflation
device after balloon preparation and prior
to delivering the stent.
9.4 DELIVERY PROCEDURE
1. Prepare vascular access site according to
standard PTCA practice.
2. Pre-dilate the lesion with a balloon diameter
0.5 mm smaller than the stent and balloon
length equal to or shorter than the target lesion
length. The length of the pre-dilatation balloon
must be shorter than the stent to be implanted.
3. Maintain neutral pressure on inflation device.
Open rotating hemostatic valve to allow for
easy passage of the stent.
Note: If resistance is encountered, DO NOT
FORCE PASSAGE. Resistance may
indicate a problem and may result in
damage to the stent if it is forced. Remove
the system and examine.
4. Ensure guide catheter stability before
advancing the Stent Delivery System into the
coronary artery. Carefully advance the Stent
Delivery System into the hub of the guide
catheter.
Note: If resistance to the Stent Delivery System
is encountered prior to exiting the guide
catheter, do not force passage. Resistance
may indicate a problem and may result in
damage to the stent if it is forced. Maintain
guidewire placement across the lesion and
remove the Stent Delivery System and guide
catheter as a single unit (See Section 9.7
STENT DELIVERY SYSTEM REMOVAL –
PRECAUTIONS).
5. Advance delivery system over the guidewire
to the target lesion under direct fluoroscopic
visualization. Utilize the proximal and
distal radiopaque markers on the balloon
as a reference point. If the position of the
stent is not optimal, it should be carefully
repositioned or removed (See Section 9.7
STENT/ DELIVERY SYSTEM REMOVAL
PRECAUTIONS). Expansion of the stent
should not be undertaken if the stent is
not properly positioned in the target lesion
segment of the vessel.
6. Sufficiently tighten the rotating hemostatic
valve. Stent is now ready to be deployed.
9.5 STENT DEPLOYMENT PROCEDURE
1. Prior to stent expansion, utilize high-resolution
fluoroscopy to verify the stent has not been
damaged or shifted during positioning.
2. Maintain inflation pressure for 15-30 seconds
for full expansion of the stent.
3. Do not exceed Rated Burst Pressure. The
Endeavor Resolute Stents should not be
expanded to a diameter beyond 0.5 mm of
its nominal expansion.
Note: In smaller or diffusely diseased vessels, the
use of high balloon inflation pressures may
over-expand the vessel distal to the stent and
could result in vessel dissection.
Note: Under-expansion of the stent may result
in stent movement. Care must be taken to
properly size the stent to ensure the stent is in
full contact with the arterial wall upon deflation
of the balloon.
9.6 REMOVAL PROCEDURE
1. Deflate the balloon by pulling negative
pressure on the inflation device. Allow
adequate time, at least 15 seconds, for full
balloon deflation. Longer stents may require
more time for deflation. Deflation of the
balloon should be confirmed by absence of
contrast within the balloon.