Johnson & Johnson Cordis Cypher Select + Mode D'emploi page 4

. Specification 10578982 Rev: 7
. DCR: 12061739 Effective: 12/9/2009
English
. IFU - Cypher Select +
5.4 Post Implant - Precautions
• Great care must be exercised when crossing a newly deployed stent
with other devices such as another stent delivery system, an intravascular
ultrasound (IVUS) catheter, a coronary guidewire or balloon catheter to
avoid disrupting the stent geometry and stent coating.
• Through non-clinical testing, single and two overlapping
Stents have been shown to be MRI safe at field strengths of 3 Tesla or less
and a maximum whole body averaged specific absorption rate (SAR) of
3.0 W/kg for 15 minutes of MRI. Single and two overlapping CYPHER
SELECT Stents should not migrate in this MRI environment. Non-clinical
testing has not been performed to rule out the possibility of stent
migration at field strengths higher than 3 Tesla. In this testing, single
CYPHER SELECT Stents up to 33 mm in length produced a temperature
rise of less than 1 degree C and two overlapped 33 mm length CYPHER
SELECT Stents produced a temperature rise of less than 2 degrees C at
a SAR of 3.0 W/kg for 15 minutes of MRI. The effect of heating in the MRI
environment for stents with fractured struts is not known. The effect of
heating in the MRI environment on the drug or polymer coating is not
known. MR imaging quality may be compromised if the area of interest is in
the exact same area or relatively close to the position of the stent.
6. Drug Interaction
While no specific clinical data are available, drugs, like tacrolimus, that act
through the same binding protein (FKBP) may interfere with the efficacy of
sirolimus.
Drug interaction studies have not been performed. Sirolimus is metabolized by
CYP3A4. Strong inhibitors of CYP3A4 (e.g. ketoconazol) might cause increased
sirolimus exposure to levels associated with systemic effects, especially if
multiple stents are deployed. Systemic exposure of sirolimus should also be
taken into consideration if the patient is treated concomitantly with systemic
immunosuppressive therapy.
7. Potential Adverse Events / Complications
Adverse events (alphabetical order) may be associated with the implantation
of a coronary stent in coronary arteries, but are not limited to the following:
• Allergic reaction
• Aneurysm
• Arrhytmias
• Death
• Dissection
• Drug reactions to antiplatelet agents / anticoagulation agents / contrast
medium
• Emboli, distal (tissue, air or thrombic emboli)
• Embolization, stent
• Failure to deliver the stent to the intended site
• Hemorrhage
• Hypotension/Hypertension
• Infection and pain at the insertion site
• Myocardial ischemia and/or infarction
• Occlusion
• Restenosis of stented segment (greater than 50% obstruction)
• Stroke
• Thrombosis (acute, subacute or late)
• Ventricular fibrillation
• Vessel spasm.
8. Individualization of Treatment
The risks and benefits should be considered for each patient before use of
the CYPHER SELECT + Sirolimus-eluting Coronary Stent. Patient selection
factors to be assessed should include a judgment regarding risk of antiplatelet
therapy. Special consideration should be given to those patients with recently
active gastritis or peptic ulcer disease.
Premorbid conditions that increase the risk of a poor initial result or the risks
of emergency referral for bypass surgery (diabetes mellitus, renal failure, and
severe obesity) should be reviewed. A review of the vessel location, reference
vessel size, lesion length, qualitative target lesion characteristics, and the
amount of myocardium in jeopardy from acute or subacute thrombosis must
also be considered.
Thrombosis following stent implantation is affected by several baseline
angiographic and procedural factors. These include vessel diameter less than
3 mm, intra-procedural thrombus, and dissection following stent implantation.
In patients who have undergone coronary stenting, the persistence of a
thrombus or dissection should be considered a marker for subsequent
thrombotic occlusion. These patients should be monitored very carefully
during the first month after stent implantation.
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8.1 Use in Special Populations
The safety and effectiveness of the CYPHER SELECT + Sirolimus-eluting
Coronary Stent has not yet been established in the following patient
populations:
• Patients with unresolved vessel thrombus at the lesion site.
®
CYPHER SELECT • Patients with coronary artery reference vessel diameter < 2.25 mm.
• Patients with unprotected lesions located in the left main coronary artery.
• Patients with tortuous vessels that may impair stent placement in the
region of the obstruction or proximal to the lesion.
• Patients under high risk for primary Percutaneous Coronary Intervention
(PCI) for acute myocardial infarction characterized by the presence of
cardiogenic shock or evidence of massive thrombus in the infarct-related
artery.
• Patients with brachytherapy treatment of the target lesion.
• Pregnant Patients: There are no adequate and well controlled studies
in pregnant women or men intending to father children. Effective
contraception should be initiated before implanting a CYPHER SELECT +
Stent and for 12 weeks after implantation. The CYPHER SELECT + Stent
should be used during pregnancy only if the potential benefit outweighs
the potential risk to the embryo or fetus.
The safety and effectiveness of using brachytherapy treatment, mechanical
atherectomy devices (directional atherectomy catheters, rotational
atherectomy catheters) or laser angioplasty catheters to treat in-stent stenosis
of a CYPHER SELECT + Sirolimus-eluting Coronary Stent has not yet been
established.
While not observed in pivotal clinical trials that supported the CYPHER
Stent Design Dossier, stent fractures are uncommon events but have been
observed in long stented segments including those in which overlapping
stents have been used. They have been observed in coronary segments that
undergo significant motion, particularly in areas with severe angulation,
tortuosity, and calcification. In the CYPHER Stent, they have been reported
most often in certain lesion subgroups in which safety and effectiveness have
not been established. The clinical implications of stent fracture are not well
characterized.
9. How Supplied
STERILE. This device is sterilized with ethylene oxide (EtO) gas and is
nonpyrogenic. Do not use the device if the package is opened or damaged.
CONTENTS: One CYPHER SELECT + Sirolimus-eluting Coronary Stent, one
flushing needle, one distension chart label.
STORAGE. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
10. Operator's Manual
10.1 Access to Package Holding Sterile Stent Delivery System & Inspection
Prior to Use
1.
Before opening, carefully inspect the stent delivery system package for
damage to the sterile barrier. Do not use if there is any damage to the
packaging.
2. Tear open the foil pouch to carefully remove the product that is packaged
in a coiled hoop and tray. Pass or drop the product into the sterile field
using an aseptic technique.
3. Prior to using the device, inspect for bends, kinks, and other damage.
10.2 Materials Required
Quantity
N/A
2-3
1,000 u / 500 cc
1
1
N/A
1
1
N/A
®
Material
Appropriate guiding catheter(s)
10-20 cc syringes
Sterile Heparinized Normal Saline (HepNS)
.014" (0.36 mm) diameter guidewire
Rotating hemostatic valve with an appropriate
internal diameter
Contrast diluted 1:1 with normal saline
Inflation device
Stopcock (3-way minimum)
Appropriate anticoagulation and anti-platelet
drugs
10578986r7_CypherSel_pdf.pdf (5 file(s) total).
10.3 Preparation
10.3.1 Rinse Catheter
Rinse the catheter with sterile heparinized saline solution.
10.3.2 Guidewire Lumen Flush
1. Attach the syringe with HepNS to the flushing needle packaged in the
blister.
2. Insert the needle into the tip of the catheter and flush the guidewire lumen
with HepNS.
Caution: AVOID manipulation of stent during flushing of guidewire lumen,
as this may disrupt the placement of the stent on the balloon.
10.3.3 Delivery System Preparation
1. Prepare inflation device with diluted contrast medium.
2. Attach inflation device to stopcock; attach to hub (balloon inflation port).
Caution: DO NOT apply negative or positive pressure to balloon at this
time.
3.
Open stopcock to stent delivery system.
4. Leave inflation device on neutral.
10.4 Delivery Procedure
1.
Prepare vascular access site according to standard practice.
2. Prepare lesion site according to standard practice.
3. Maintain neutral pressure on inflation device. Open rotating hemostatic
valve as widely as possible.
4. Backload delivery system onto proximal portion of guidewire while
maintaining guidewire position across target lesion.
5. Advance the stent delivery system over guidewire to target lesion. Use
radiopaque balloon markers to position stent across lesion; perform
angiography to confirm stent position.
Note: Should unusual resistance be felt at any time during either lesion
access or removal of the stent delivery system before stent implantation,
the entire system should be removed. See Stent/System Removal -
Precautions section (5.3) for specific stent delivery system removal
instructions.
10.5 Deployment Procedure
1.
Before deployment, reconfirm the correct position of the stent relative to
the target lesion via the radiopaque balloon markers.
2.
Attach the inflation device (only partially filled with contrast media) to a
stopcock (three-way minimum) and apply negative pressure to purge the
balloon of air.
3. Turn the stopcock to the off position to the catheter and purge the inflation
device of air. Close the side port of the stopcock.
4. Under fluoroscopic visualization, inflate the balloon to deploy the stent
but do not exceed the labeled rated burst pressure. Optimal expansion
requires the stent to be in full contact with the artery wall, with the stent
internal diameter matching the size of the reference vessel diameter.
Stent wall contact should be verified through routine angiography or
intravascular ultrasound.
5.
Deflate the balloon by pulling a vacuum with the inflation device. Make
sure the balloon is fully deflated before any attempted movement of the
catheter.
6. Confirm adequate stent expansion by angiographic injection through the
guiding catheter.
10.6 Further Dilatation of Stented Segments
All efforts should be taken to assure that the stent is not underdilated. If the
deployed stent size is still inadequate with respect to vessel diameter, or if full
contact with the vessel wall is not achieved, a larger balloon may be used to
expand the stent further. If the initial angiographic results are suboptimal, the
stent may be further expanded using a low profile, high pressure, and non-
compliant balloon catheter. If this is required, the stented segment should be
recrossed carefully with a prolapsed guidewire to avoid dislodging the stent.
Caution: Do not dilate the stent beyond the following limits:
Nominal Stent Diameter Dilatation Limits
2.25 mm – 3.00 mm 3.50 mm
3.50 mm 4.50 mm
10.7 Removal Procedure
1. Ensure that the balloon is fully deflated.
2. While maintaining guidewire position and negative pressure on the
inflation device, withdraw the stent delivery system.
Note: Should unusual resistance be felt at any time during either lesion
access or removal of the stent delivery system before stent implantation,
the entire system should be removed. See Stent/System Removal -
Precautions section (5.3) for specific stent delivery system removal
instructions.
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