Stent Deployment Procedure (Reference Figure 1); Post Procedure; References; Warranty - Boston Scientific Epic Mode D'emploi

Precaution: Physicians should use judgement based on experience in dilating
arterial lesions and/or obstructions. Never force a balloon catheter to inflate to
the point of risking dissection of the arterial wall.
After the lesion has been properly dilated, remove the dilatation catheter,
leaving the guidewire with the tip distal to the lesion for stent system
advancement.
. Place the Epic™ Nitinol Vascular Stent System over the guidewire. Advance
the delivery system as a unit through the hemostatic valve of the introducer
sheath.

Stent Deployment Procedure (Reference Figure 1)

1. Advance the delivery system until the stent radiopaque markers
centered over the target lesion.
Precaution: If unable to initiate release of the stent or if strong resistance is
met with the introduction of the delivery system, remove the entire system
from the patient and introduce a new system. Do not use a power injector
through the delivery system for angiography.
. Remove the safety lock positioned on the rack
that the radiopaque markers are still properly positioned across the target
lesion. Keep the entire length of the delivery system as straight as possible and
maintain slight backward tension on the delivery system during deployment.
Note: If repositioning of the delivery system is required, reinserting the safety
lock will prevent inadvertent deployment.
Deploy the stent by one of the following methods:
A. Roll the thumb wheel of the deployment handle in a proximal direction.
⑤
Continue to roll thumb wheel until the radiopaque marker of the exterior
shaft passes the proximal radiopaque markers of the stent resulting in full
⑥
deployment. Do not continue to roll the thumb wheel after the stent is fully
deployed.
B. Grasp the manual pull grip and pull toward the deployment handle. Continue
④
to pull back until the radiopaque marker of the exterior shaft
proximal radiopaque markers of the stent resulting in full deployment. Do not
continue to pull back the manual grip after the stent is fully deployed. Note: Do
not restrict movement of the thumb wheel
could be encountered.
C. (Combination) Any combination of A and B can be used to achieve full
deployment.
3. When released from the delivery system, the stent will immediately expand
into position. View the delivery system under fluoroscopy, ensuring that the
exterior shaft marker band has crossed the proximal stent markers. The
⑥
delivery system can now be withdrawn. Use caution when withdrawing the
stent delivery system and always manipulate under fluoroscopy. If unusual
resistance is felt, readvance and rotate the delivery system in an attempt to
center the delivery system within the vessel, then carefully attempt repeat
withdrawal.
and are
① ②
by pulling vertically. Confirm
③
passes the
⑥
otherwise deployment difficulties
⑤
. If incomplete expansion exists within the stent at any point along the lesion,
balloon dilatation can be performed utilizing standard PTA technique.
Precaution: Never dilate the stent using a balloon that is larger in diameter
than the unconstrained diameter of the stent.
5. Withdraw guidewire and sheath from patient and establish hemostasis per
conventional technique.

Post Procedure

Assess patient for hematoma and/or other signs of bleeding at the puncture site.

rEfErEnCES

The physician should consult recent literature on current medical practice on stent
implantation.

warranTy

Boston Scientific Corporation (BSC) warrants that reasonable care has been
used in the design and manufacture of this instrument. This warranty is in lieu
of and excludes all other warranties not expressly set forth herein, whether
express or implied by operation of law or otherwise, including, but not limited
to, any implied warranties of merchantability or fitness for a particular purpose.
Handling, storage, cleaning and sterilization of this instrument as well as other
factors relating to the patient, diagnosis, treatment, surgical procedures and
other matters beyond BSC's control directly affect the instrument and the results
obtained from its use. BSC's obligation under this warranty is limited to the repair
or replacement of this instrument and BSC shall not be liable for any incidental
or consequential loss, damage or expense directly or indirectly arising from the
use of this instrument. BSC neither assumes, nor authorizes any other person to
assume for it, any other or additional liability or responsibility in connection with
this instrument. bSC assumes no liability with respect to instruments reused,
reprocessed or resterilized and makes no warranties, express or implied,
including but not limited to merchantability or fitness for a particular purpose,
with respect to such instruments.
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