Contraindications - Johnson & Johnson Cordis Cypher Select + Mode D'emploi

. Specification 10578982 Rev: 7
. DCR: 12061739 Effective: 12/9/2009
. IFU - Cypher Select +
STERILE. Sterilized with ethylene oxide gas. Nonpyrogenic. For one use
only. Do not resterilize.
Caution: Not available for sale in the USA.
1. Device Description
®
The CYPHER SELECT + Sirolimus-eluting Coronary Stent includes:
• A balloon-expandable intracoronary 316L stainless steel stent premounted
onto the balloon of a delivery catheter. The stent is laser cut from seamless
tubing and electropolished. It is available in lengths of 8, 13, 18, 23, 28 and
33 mm and diameters of 2.25, 2.50, 2.75, 3.00, and 3.50 mm.
• A stent coating that consists of a blend of sirolimus and polymers.
®
• A DURALYN delivery balloon at the distal end of the catheter. The balloon
is designed to expand to a controlled diameter and length when inflated.
The balloon delivery catheter has two platinum iridium radiopaque marker
bands defining the length and location of the mounted stent.
• The usable length of the delivery system is 140 cm with a shaft profile
of 1.9F (.64 mm) / 2.7F (.90 mm) (proximal/distal). The catheter has a
distal port (hole) approximately 25 cm from the distal tip that accesses
the guidewire lumen. The guidewire lumen begins at the distal port and
terminates at the distal tip. A marker on the distal shaft identifies the distal
port. The catheter also has two markers on the proximal catheter shaft
that indicate, approximately, the exit of the balloon catheter tip from the
guiding catheter (brachial: 90 cm; femoral: 100 cm).
• The product code format is CRBxxyyy where xx is the nominal stent length
(08, 13, 18, 23, 28, or 33 mm) and yyy is the nominal stent diameter (2.25,
2.50, 2.75, 3.00, or 3.50 mm). CYPHER SELECT + is available in all diameter
and length combinations.
• The rated burst pressure of all balloons is 16 atm.
• The drug content on a stent is approximately 140
amount of 419 µg on the largest stent (3.50 x 33 mm).
2. Indications
The CYPHER SELECT + Sirolimus-eluting Coronary Stent is indicated for
improving coronary luminal diameter in:
• Patients with symptomatic ischemic disease due to discrete
stent restenotic lesions (length ≤ 30 mm) in native coronary arteries with a
reference vessel diameter of 2.25 mm to 4.00 mm;
• Patients undergoing primary percutaneous coronary intervention for acute
ST segment elevation myocardial infarction due to de novo lesions
(length ≤ 30 mm) in a native coronary artery with a reference vessel
diameter of 2.25 mm to 4.00 mm;
• Patients with multi-vessel disease, where there is 50% or greater diameter
reduction in two or more native coronary arteries. These arteries must be
≥ 2.25 mm and ≤ 4 mm in diameter adjacent to the site of the stenosis;
• Patients with symptomatic ischemic disease and diabetes mellitus
presenting discrete de novo and in-stent restenotic lesions (length ≤ 30 mm)
in native coronary arteries with a reference vessel diameter of 2.25 mm to
4.00 mm;
• Patients with symptomatic ischemic disease due to a chronic total
occlusion in native coronary arteries with a reference vessel diameter of
2.25 mm to 4.00 mm.
In patients with a chronic total occlusion, the CYPHER
Stent has been shown to significantly reduce binary restenosis, repeat target
lesion revascularization, and angiographic late loss up to 12 months after
implantation, when compared to a bare metal stent.
The CYPHER Sirolimus-eluting Stent has been shown to significantly reduce
binary restenosis, repeat target lesion revascularization, and angiographic late
loss at six months, when compared to an uncoated stent. The CYPHER Stent
has also been shown to significantly reduce binary restenosis and late loss at
8 months and target lesion revascularization at 12 months in patients with
acute myocardial infarction.
In patients with multivessel disease, treatment with CYPHER Sirolimus-eluting
Stent has shown significant reduction in MACCE (including death, stroke,
myocardial infarction, target vessel CABG and target vessel re-vascularisation)
and re-intervention rates at 3 years when compared to treatment with an
uncoated stent may show comparable results to bypass surgery in selected
patients.
In patients with diabetes mellitus, the CYPHER Sirolimus-eluting Stent
has been shown to significantly reduce binary restenosis, repeat target
lesion revascularization, and angiographic late loss up to 24 months after
implantation, when compared to a bare metal stent.
* Ethiodol and Lipiodol are trademarks of Guerbet S.A.
3.

Contraindications

Coronary artery stenting is generally contraindicated in the following patient
types:
• Patients in whom antiplatelet and/or anticoagulation therapy is
contraindicated.
• Patients judged to have a lesion that prevents complete inflation of an
angioplasty balloon.
• Transplant patients.
4. Warnings
• The use of this device carries the associated risks of subacute thrombosis,
vascular complications and/or bleeding events.
• The device should not be used in patients with a known hypersensitivity
to sirolimus or 316L stainless steel, polymethacrylates or polyolefin
copolymers.
• The device should be manipulated while under high-quality fluoroscopic
observation. Do not advance or retract the catheter unless the balloon
is fully deflated under vacuum. If resistance is met during manipulation,
determine the cause of resistance before proceeding.
• Never try to straighten a kinked hypotube. Straightening a kinked metal
shaft may result in breakage of the shaft.
• Balloon pressure should not exceed the rated burst pressure. The rated
burst pressure is based on the results of in vitro testing. At least 99.9% of
the balloons (with 95% confidence) will not burst at or below their rated
burst pressure. Use of a pressure-monitoring device is recommended to
prevent over-pressurization.
• Use the device before the "Use By" date specified on the package.
• In patients at high risk of bleeding or where prolonged administration of
clopidogrel is known to be unlikely (i.e. major extracardiac surgery planned
soon, patient not likely to be compliant with antiplatelet therapy), CYPHER
µg/cm 2 , with a maximum SELECT + Stents should be used with caution.
5. Precautions (see also
• Only physicians who have received adequate training should perform
implantation of the stent.
• Stent placement should only be performed at hospitals where emergency
de novo and in- coronary artery bypass graft surgery is readily available.
• Subsequent stent blockage may require repeat dilatation of the arterial
segment containing the stent. The long-term outcome following repeat
dilatation of endothelialized stents is not well characterized.
• Nominal stent foreshortening is 1 mm or less for stent sizes less than or
equal to 3.50 mm in diameter.
• To avoid the possibility of dissimilar metal corrosion, do not implant stents
of different materials in tandem where overlap or contact is possible.
• Do not use with Ethiodol or Lipiodol contrast media.*
• Do not expose the delivery system to organic solvents such as alcohol, or
detergents.
• Care should be taken when inserting the delivery system into the
hemostasis valve in order to avoid kinking.
• During withdrawal of the delivery system, hold a saline-soaked gauze
around the exposed catheter shaft and pull the catheter through the gauze
to remove any excess contrast medium.
• The foil pouch is the sterile barrier.
foil pouch should be considered sterile.
®
• The foil pouch is present to extend the useful shelf life of the
Sirolimus-eluting
SELECT + Sirolimus-eluting Coronary Stent. Do not remove contents from
foil pouch until immediately prior to use.
• Stent thrombosis is a low frequency event that current drug-eluting stent
(DES) clinical trials are not adequately powered to fully characterize. Stent
thrombosis is frequently associated with MI or death. Data from CYPHER
Stent randomized clinical trials (RAVEL and SIRIUS) have been prospectively
evaluated and adjudicated using both the protocol definition of stent
thrombosis and the definition developed by the Academic Research
Consortium (ARC), and demonstrate specific patterns of stent thrombosis
that vary depending on the definition used. In the CYPHER Stent clinical
trials analyzed to date, differences in the incidence of stent thrombosis
observed with the CYPHER Stent when compared to bare-metal stents
have not been associated with an increased risk of cardiac death,
myocardial infarction, or all-cause mortality. Additional data from longer-
term follow-up in the randomized clinical trials on the CYPHER Stent and
analyses of DES-related stent thrombosis are expected and should be
considered in making treatment decisions as data become available.
• To avoid the possibility of balloon and stent damage by calcified lesions,
care should be taken when maneuvering the product.
• When drug-eluting stents are used outside the specified Indications for
Use, patient outcomes may differ from the results observed in the pivotal
trials.
• Compared to use within the specified Indications for Use, the use of drug-
eluting stents in patients and lesions outside the labeled indications may
have an increased risk of adverse events, including stent thrombosis, stent
embolization, myocardial infarction, or death.
Individualization of Treatment)
Therefore, only the contents of the
CYPHER
10578986r7_CypherSel_pdf.pdf (5 file(s) total).
5.1 Stent Handling - Precautions
• For one use only. Do not resterilize or reuse. Note product "Use By" date.
Do not induce a vacuum on the delivery system before reaching the
•
target lesion.
Do not remove stent from the delivery balloon
•
stent coating and stent and may lead to embolization. Special care must be
taken not to handle or in any way disrupt the stent coating and the stent
itself on the balloon. This is most important during the catheter removal
from the package and placement over the guidewire and advancement
through the large bore hemostatic valve and guiding catheter.
• Manipulation, e.g., rolling the mounted stent with your fingers, may loosen
the stent from the delivery system balloon and cause dislodgment.
• 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.
• When backloading catheter on the guidewire, provide adequate support
to shaft segments.
5.2 Stent Placement - Precautions
• Do not prepare balloon prior to stent deployment other than as
directed. Do not pre-inflate balloon. Use balloon purging technique
described in the Operator's Manual in Section 10.
• Guiding catheters used must have lumen sizes that are suitable to
accommodate the introduction of the 2.7F Stent Delivery System. (Refer to
package label for recommended guiding catheter.)
• Do not induce a negative pressure on the delivery catheter before
placement of the stent across the lesion. This may cause premature
dislodgment of the stent from the balloon.
• Implanting a stent may lead to a dissection of the vessel distal and/or
proximal to the stented portion and may cause acute closure of the vessel
requiring additional intervention (CABG, further dilatation, placement of
additional stents, or other).
• Do not expand the stent if it is not properly positioned in the vessel. (See
Stent/System Removal - Precautions.)
• Placement of the stent has the potential to compromise side branch
patency.
• Balloon pressures should be monitored during inflation.
rated burst pressure as indicated on the product label. Use of pressures
higher than specified on product label may result in ruptured balloon with
possible intimal damage and dissection.
• Should any resistance be felt at any time during either lesion access or
removal of the stent delivery system pre-stent implantation, the system
should be removed per instructions in Section 5.3 below.
• 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.
• If reinserting the catheter, flush the guidewire lumen using the flushing
needle before reinsertion.
• Additional expansion of a deployed stent may cause a flow limiting
dissection. This may be treated by implantation of another stent. When
multiple stents are implanted, the ends should overlap slightly.
• When treating multiple lesions, the distal lesion should be initially stented,
followed by stenting of the proximal lesion. Stenting in this order obviates
the need to cross the proximal stent in placement of the distal stent and
reduces the chances for dislodging the proximal stent.
5.3 Stent/System Removal - Precautions
Should unusual resistance be felt at any time during either lesion access
or removal of the stent delivery system pre-stent implantation, the entire
system must be removed as a single unit. When removing the delivery system
as a single unit, do not retract the delivery system into the guiding catheter.
Advance the guidewire into the coronary anatomy as far distally as safely
possible. Tighten the rotating hemostatic valve to secure the stent delivery
system to the guiding catheter, then remove the guiding catheter and stent
delivery system as a single unit.
Failure to follow these steps and/or applying excessive force to the stent
delivery system can potentially result in loss or damage to the stent and/or
stent delivery system components.
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English
as removal may damage
Do not exceed
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