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8.0 PATIENT SELECTION AND TREATMENT
8.1 Individualization of Treatment
9.0 CLINICIAN USE INFORMATION
9.1 Inspection Prior to Use
9.2 Materials Required
9.3 Preparation
9.3.1 Packaging Removal
9.3.2 Guide Wire Lumen Flush
9.3.3 Delivery System Preparation
9.4 Delivery Procedure
9.5 Deployment Procedure
9.6 Removal Procedure
9.7 Post-deployment Dilation of Stent Segments
10.0 SPIRIT AND XIENCE FAMILY OF CLINICAL TRIALS
10.1 Pre-Market Clinical Trials
Table 10.1-1: SPIRIT Family of XIENCE V Clinical Trial Designs (Pre-market)
Table 10.1-2: SPIRIT Family of Clinical Trials Angiographic Results (Pre-market)
Table 10.1-3: SPIRIT Family of Clinical Trials Principal 1-Year Clinical Outcomes
(Pre-market)
Table 10.1-4: SPIRIT Family of Clinical Trials Principal Clinical Outcomes from
Latest Follow-up (Pre-market)
10.2 Post-Market Clinical Trials
Table 10.2-1: SPIRIT and XIENCE V Family Clinical Trial Designs (Post-market)
Table 10.2-2: SPIRIT and XIENCE V Family of Trials Principal Clinical Outcomes
(Post-market)
10.3 Pooled Clinical Trials Analysis for Stent Thrombosis Subsequent to DAPT
Interruption / Discontinuation
Table 10.3-1: Stent Thrombosis (ARC Definite / Probable) Subsequent to DAPT
Interruption / Discontinuation through 730 days Versus No Interruption; Pooled Data
from 7 Pre- and Post-market Trials
11.0 HOW SUPPLIED
12.0 PATENTS AND TRADEMARKS
XIENCE Sierra
Everolimus Eluting Coronary Stent System
INFORMATION FOR PRESCRIBERS
Table of Contents
1.0 DEVICE DESCRIPTION
Table 1-1: Product Name and Sizes
Table 1-2: Drug Content in the XIENCE Sierra
Everolimus Eluting Coronary Stents
Table 1-3:
In vitro
Device Specifications
2.0 INDICATIONS
3.0 CONTRAINDICATIONS
4.0 WARNINGS
5.0 PRECAUTIONS
5.1 Stent Handling
5.2 Stent Placement
5.3 Use in Conjunction with Other Procedures
5.4 Stent / System Removal
5.5 Post Implant
5.6 Use in Special Populations
5.6.1 Pregnancy
5.6.2 Lactation
5.6.3 Pediatric use
5.7 Magnetic Resonance Imaging Safety Information (MRI)
5.8 Drug Interactions
5.9 Immune Suppression Potential
5.10 Lipid Elevation Potential
6.0 DRUG INFORMATION
6.1 Interactions with Drugs or Other Substances
6.2 Pregnancy
6.3 Lactation
7.0 POTENTIAL ADVERSE EVENTS
•
Two radiopaque markers, located underneath the balloon, fluoroscopically mark the working length of the balloon and the expanded stent length.
•
Two proximal delivery system shaft markers (95 cm and 105 cm proximal to the distal tip) indicate the relative position of the delivery system to the end of the brachial or femoral
guiding catheter. Working catheter length is 145 cm.
•
A shaft color change denotes the guide wire exit notch.
Table 1-3: In vitro Device Specifications
Stent Diameter
(mm)
Stent Length
(mm)
* Minimum
Guiding Catheter Compatibility (ID)
** in vitro Stent Nominal Pressure
Rated Burst Pressure (RBP)
Stent Free
Area
(%)
(atm)
kPa
(atm)
kPa
2.0
8, 12, 15, 18, 23, 28, 33, 38
5F (0.056” / 1.42 mm)
9
912
16
1621
81
2.25
8, 12, 15, 18, 23, 28, 33, 38
5F (0.056” / 1.42 mm)
9
912
16
1621
83
2.5
8, 12, 15, 18, 23, 28, 33, 38
5F (0.056” / 1.42 mm)
9
912
16
1621
84
2.75
8, 12, 15, 18, 23, 28, 33, 38
5F (0.056” / 1.42 mm)
12
1216
16
1621
86
3.0
8, 12, 15, 18, 23, 28, 33, 38
5F (0.056” / 1.42 mm)
12
1216
16
1621
87
3.25
8, 12, 15, 18, 23, 28, 33, 38
5F (0.056” / 1.42 mm)
12
1216
16
1621
88
3.5
8, 12, 15, 18, 23, 28, 33, 38
5F (0.056” / 1.42 mm)
12
1216
16
1621
84
4.0
8, 12, 15, 18, 23, 28, 33, 38
5F (0.056” / 1.42 mm)
12
1216
16
1621
86
*
See individual manufacturer specifications for (F) equivalent.
** Assure full deployment of the stent (see
Section 9.5 Deployment Procedure
). Deployment pressures should be based on lesion characteristics.
2.0 INDICATIONS
The XIENCE Sierra Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in the following:
•
Patients with symptomatic ischemic heart disease due to discrete
de novo
native coronary artery lesions.
•
For restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset.
•
For the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels), lesions residing within small
coronary vessels; lesions where treatment results in the jailing of side branches (lesions with a side branch < 2 mm in diameter or an ostial stenosis < 50%); for the treatment of
elderly patients (age ≥ 65), and for treatment of both men and women.
1.0 DEVICE DESCRIPTION
The XIENCE
Sierra Everolimus Eluting Coronary Stent System (EECSS) includes:
A pre-mounted L-605 cobalt chromium (CoCr) alloy XIENCE Sierra stent with a coating that consists of a blend of the anti-proliferative drug everolimus and polymers. The product
family consists of:
Table 1-1: Product Name and Sizes
Product Name
Stent Diameter (mm)
Stent Length (mm)
XIENCE
Sierra
2.0, 2.25, 2.5, 2.75, 3.0, 3.25, 3.5, 4.0
8, 12, 15, 18, 23, 28, 33, 38
The available dose of everolimus on the stent varies by size as follows:
Table 1-2: Drug Content in the XIENCE Sierra Everolimus Eluting Coronary Stents
Stent Diameter
(mm)
Stent Length
(mm)
Drug Dose
(µg)
2.0, 2.25, 2.5, 2.75, 3.0, 3.25
8
39
2.0, 2.25, 2.5, 2.75, 3.0, 3.25
12
58
2.0, 2.25, 2.5, 2.75, 3.0, 3.25
15
72
2.0, 2.25, 2.5, 2.75, 3.0, 3.25
18
85
2.0, 2.25, 2.5, 2.75, 3.0, 3.25
23
111
2.0, 2.25, 2.5, 2.75, 3.0, 3.25
28
131
2.0, 2.25, 2.5, 2.75, 3.0, 3.25
33
157
2.0, 2.25, 2.5, 2.75, 3.0, 3.25
38
177
Stent Diameter
(mm)
Stent Length
(mm)
Drug Dose
(µg)
3.5, 4.0
8
53
3.5, 4.0
12
72
3.5, 4.0
15
99
3.5, 4.0
18
117
3.5, 4.0
23
145
3.5, 4.0
28
181
3.5, 4.0
33
209
3.5, 4.0
38
236
•
For the treatment of patients presenting with in-stent restenosis in coronary artery
lesions; chronic total occluded coronary artery lesions (defined as coronary artery
lesions with TIMI flow 0 and lasting longer than 3 months); and coronary artery
bifurcation lesions.
In all cases, the treated lesion length should be less than the nominal stent length (8 mm,
12 mm, 15 mm, 18 mm, 23 mm, 28 mm, 33 mm, or 38 mm) with a reference vessel
diameter of ≥ 2.00 mm and ≤ 4.25 mm.
3.0 CONTRAINDICATIONS
The XIENCE Sierra Everolimus Eluting Coronary Stent System is contraindicated for use in:
•
Patients who cannot tolerate, including allergy or hypersensitivity to, procedural
anticoagulation or the post procedural antiplatelet regimen.
•
Patients with hypersensitivity or contraindication to everolimus or structurally related
compounds, or known hypersensitivity to stent components (cobalt, chromium,
nickel, tungsten, acrylic, fluoropolymers), or with contrast sensitivity.
4.0 WARNINGS
•
For single use only. Do not resterilize or reuse. Note the product "Use by" date on
the package.
•
It is not recommended to treat patients having a lesion that prevents complete
inflation of an angioplasty balloon
•
Antiplatelet therapy should be administered post-procedure (See
Section 8.1,
Individualization of Treatment
).
•
This product should not be used in patients who are not likely to comply with the
recommended antiplatelet therapy.
•
Judicious selection of patients is necessary, since the use of this device carries the
associated risk of stent thrombosis, vascular complications, and / or bleeding events.
5.0 PRECAUTIONS
5.1 Stent Handling
•
Implantation of the stent should be performed only by physicians who have received
appropriate training.
•
Stent placement should only be performed at centers where emergency coronary
artery bypass graft (CABG) is available.
• The foil pouch is not a sterile barrier.
The inner header bag (pouch) within the
foil pouch is the sterile barrier.
Only the contents of the inner pouch should be
considered sterile. The outside surface of the inner pouch is NOT sterile.
•
To confirm sterility has been maintained, ensure that the inner package sterile barrier
has not been opened or damaged prior to use.
•
Care should be taken to control the guiding catheter tip during stent delivery,
deployment, and balloon withdrawal. Before withdrawing the stent delivery system,
visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter
movement into the vessel and subsequent arterial damage.
•
Special care must be taken not to handle or in any way disrupt the stent on the
balloon. This is most important during catheter removal from packaging, placement
over the guide wire, and advancement through the rotating hemostatic valve adapter
and guiding catheter hub.
• Do not manipulate, touch, or handle the stent,
as this may cause coating damage,
contamination, or dislodgement of the stent from the delivery balloon.
•
Use only the appropriate balloon inflation media. Do not use air or any gaseous
medium to inflate the balloon, as this may cause uneven expansion and difficulty
in deployment of the stent. If gaseous medium is used and balloon rupture occurs,
there is the potential of causing air embolism and / or vessel injury.
5.2 Stent Placement
•
Use guiding catheters which have lumen sizes that are suitable to accommodate the
stent delivery system.
•
Do not prepare or pre-inflate the delivery system prior to stent deployment other than
as directed. Use balloon purging technique described under
Section 9.3.3, Delivery
System Preparation.
•
When pre-dilatation is performed, an appropriate balloon size should be used. Failure to do
so may increase the difficulty of stent placement and cause procedural complications.
•
The decision to pre-dilate the lesion with an appropriate sized balloon should be
based on patient and lesion characteristics. Direct stenting in less complex coronary
lesions has been shown to be as effective and safe as stenting with pre-dilation for
device lengths up to 28 mm in real-world settings. If pre-dilation is performed, limit
the length of pre-dilation by the PTCA balloon to avoid creating a region of vessel
injury that is outside the boundaries of the implanted stent.
•
When introducing the delivery system into the vessel, do not induce negative pressure
on the delivery system. This may cause dislodgement of the stent from the balloon.
•
Do not torque the catheter more than one (1) full turn.
•
Implanting a stent may lead to dissection of the vessel distal and / or proximal to the
stent, and may cause abrupt closure of the vessel, requiring additional intervention
(CABG, further dilation, placement of additional stents, or other).
•
An unexpanded stent may be retracted into the guiding catheter one time only. An
unexpanded stent should not be reintroduced into the artery once it has been pulled
back into the guiding catheter. Subsequent movement in and out through the distal
end of the guiding catheter should not be performed, as the stent may be damaged
or dislodged during retraction back into the guiding catheter.
•
Should resistance be felt at any time during removal of the undeployed coronary stent
system, please refer to the steps provided in
Section 5.4 Stent / System Removal
.
•
Do not expand the stent if it is not properly positioned in the vessel. (See
Section 5.4
Stent / System Removal
)
•
The inflated balloon diameter of the system used to deploy the stent should
approximate the diameter of the vessel. Oversizing of the stent can result in a
ruptured vessel. To ensure full expansion of the stent, the balloon should be inflated
to a minimum of nominal pressure.
•
Do not exceed the Rated Burst Pressure (RBP) as indicated on product label. Monitor
balloon pressures inflation. Use of pressures higher than specified on product label
may result in a ruptured balloon with possible intimal damage and dissection.
•
When performed, post-dilatation should be performed at high pressure with a
noncompliant balloon.
•
Under-expansion of the stent may result in stent movement. Care must be taken to
properly size the stent to ensure that the stent is in full contact with the arterial wall
upon deflation of the balloon. All efforts should be made to assure that the stent is
not under dilated. Refer to
Section 9.0 Clinician Use Information
.
•
Placement of a stent has the potential to compromise side branch patency.
•
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 may include bleeding, hematoma, or pseudoaneurysm.
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Printed on : 2017-11-03
