Precautions; General Precautions; Stent System Handling (Also See, Operational Instructions); Stent Placement - Boston Scientific SYNERGY Mode D'emploi

• Patients with known hypersensitivity to platinum or stainless steel may suffer an allergic
reaction to this implant.

precaUtIons

General precautions

• Only physicians who have received adequate training should perform implantation of the stent.
• Stent placement should only be performed at hospitals where emergency coronary artery
bypass graft (CABG) surgery is readily available.
• Potential interactions of the SYNERGY™ stent with other drug-eluting or coated stents
have not been evaluated.
• Subsequent restenosis may require repeat dilatation of the arterial segment containing
the stent. The long-term outcome following repeat dilatation of coronary stents is
unknown at present.
• Consideration should be given to the risks and benefits of use in patients with a history of
severe reaction to contrast agents.
• Do not expose the stent delivery system to organic solvents such as alcohol or detergents.
• Care should be taken to control the position of the guide catheter tip during stent delivery,
deployment, and balloon withdrawal. Before withdrawing the stent delivery system (SDS),
visually confirm complete balloon deflation by fluoroscopy (see Table 3., Representative
System Deflation Times). Failure to do so may cause increased SDS withdrawal forces
and result in guide catheter movement into the vessel and subsequent arterial damage.
• Orally administered everolimus combined with cyclosporine is associated with increased
serum cholesterol and triglyceride levels.

stent system Handling (also see, operational Instructions)

• For single use only. Do not resterilize or reuse this product. Note product ''Use By'' date
and do not use after the "Use By" date.
• The SYNERGY stent and its delivery system are designed for use as a unit. The stent is
not to be removed from its delivery balloon. The stent is not designed to be crimped onto
another balloon. Removing the stent from its delivery balloon may damage the stent and
coating and/or lead to stent embolization.
• Prior to angioplasty, carefully examine all equipment to be used during the procedure
including the dilatation catheter to verify proper function.
• Special care must be taken not to handle or in any way disrupt the stent position on the
delivery balloon. This is most important during catheter removal from packaging, placement
over the guidewire, and advancement through the hemostatic valve and guide catheter hub.
• Excessive manipulation or handling may cause coating damage, contamination, or
dislodgment of the stent from the delivery balloon.
• Use only the appropriate balloon inflation media (see operational Instructions, balloon
preparation). DO NOT use air or any gas medium to inflate the balloon.
• In the event that the SYNERGY stent is not deployed, follow product return procedures
and avoid handling of the stent with bare hands.
• Stent contact with any fluid prior to placement is not recommended as there is a
possibility of drug release. However, if it is absolutely necessary to flush or soak the stent
with sterile/isotonic saline, contact time should be limited (1 minute maximum).

stent placement

preparation

• DO NOT PREPARE OR PRE-INFLATE BALLOON PRIOR TO STENT DEPLOYMENT OTHER
THAN AS DIRECTED. Use the balloon purging technique described in operational
Instructions, balloon preparation.
• If unusual resistance is felt at any time during lesion access before stent implantation,
the stent system and guide catheter should be removed as a single unit (see stent
system removal - pre-deployment and stent system removal - post-deployment).
• An unexpanded stent should be introduced into the coronary arteries one time only. An
unexpanded stent should not be subsequently moved in and out through the distal end of the
guide catheter as stent or coating damage or stent dislodgment from the balloon may occur.

placement

• The vessel should be pre-dilated with an appropriately sized balloon. Failure to do so may
increase the risk of placement difficulty and procedural complications.
• Do not expand the stent if it is not properly positioned in the vessel (see precautions,

stent system removal - pre-deployment).

• Balloon pressures should be monitored during inflation. Do not exceed the rated burst
pressure as indicated on the product label (see Table 4., SYNERGY Compliance Chart).
Use of pressures higher than specified on the product label may result in a ruptured
balloon or shaft. This may result in potential intimal damage, dissection or vessel rupture.
• The stent inner diameter should approximate 1.1 times the distal reference vessel
diameter.
• Placement of the stent has the potential to compromise side branch patency if stenting
near a side branch.
• 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 dilation, placement of additional stents, or other).
• When treating multiple lesions, the distal lesion should generally be stented first,
followed by stenting of the more proximal lesion(s). Stenting in this order avoids the
requirement to cross the proximal stent when placing the distal stent and reduces the
chances of the stent dislodgment.
stent system removal - pre-deployment
• If unusual resistance is felt at any time during lesion access before stent implantation, the
stent system and the guide catheter should be removed as a single unit (see note below).
• Do not attempt to pull an unexpanded stent back into the guide catheter, as stent or
coating damage or stent dislodgment from the balloon may occur.
• Stent retrieval methods (use of additional wires, snares, and/or forceps) may result in
additional trauma to the vascular site. Complications can include bleeding, hematoma, or
pseudoaneurysm.
note: When removing the entire stent system and guide catheter as a single unit the
following steps should be executed in the order indicated under direct visualization using
fluoroscopy.
• If greater than usual resistance is felt during delivery system withdrawal, pay particular
attention to guide catheter position. In some cases it may be necessary to pull back
slightly on the guide catheter in order to prevent deep seating (unplanned advancement)
of the guide catheter and subsequent vessel damage. In cases where unplanned guide
catheter movement has occurred, angiographic assessment of the coronary tree should
be undertaken to ensure that there is no damage to the coronary vasculature.
• Maintain guidewire placement across the lesion during the entire removal process.
Carefully pull back the stent system until the proximal balloon marker of the stent system
is just distal to the guide catheter distal tip.
• The stent system and the guide catheter should be pulled back as a single unit until the
tip of the guide catheter is just distal to the arterial sheath, allowing the guide catheter to
straighten. Carefully retract the un-deployed stent into the tip of the guide catheter and
remove the stent system and the guide catheter from the patient again as a single unit
while leaving the guidewire across the lesion.

stent system removal - post-deployment

• Following stent placement, confirm complete balloon deflation (Table 3., Representative
System Deflation Times).
• If greater than usual resistance is felt during delivery system withdrawal, pay particular
attention to guide catheter position. In some cases it may be necessary to pull back
slightly on the guide catheter in order to prevent deep seating (unplanned advancement)
of the guide catheter and subsequent vessel damage. In cases where unplanned guide
catheter movement has occurred, angiographic assessment of the coronary tree should
be undertaken to ensure that there is no damage to the coronary vasculature.
5
Black (K) ∆E ≤5.0