Recommended Method Of Deployment - Boston Scientific ELUVIA Mode D'emploi

Precaution: If strong resistance is met with the introduction of the delivery system
or if unable to initiate release of the stent, remove the entire system from the
patient and introduce a new system.
Note: For optimal performance, keep the entire length of the delivery system that is
outside the body as straight and stable as possible. To do so, remove slack from the
system, maintain slight backward tension on the delivery system, and anchor the
handle on the patient or operating table during deployment. Alternatively, the operator
may straighten and stabilize the distal end of the blue outer shaft during deployment.
Note: Failure to eliminate slack (Reference Figure 5) and/or curvature of the
delivery system catheter between the introducer/guide sheath and the delivery
system handle during deployment may adversely affect deployment accuracy,
especially in ipsilateral cases.
Note: If repositioning of the stent delivery system is required, reinserting the
thumbwheel lock will prevent inadvertent deployment.
Figure 5. Eliminate slack

10.10 Recommended Method of Deployment

1. While using fluoroscopy maintain position of the distal and proximal stent
radiopaque markers [1] relative to the targeted site. Roll the thumbwheel [4] of the
deployment handle in the direction of the arrow indicated on the handle. Continue
to roll thumbwheel until the middle shaft radiopaque marker band [5] passes the
distal stent radiopaque markers. Watch for the distal stent radiopaque markers to
begin separating: separation of the distal stent radiopaque markers signals that
the stent is deploying.
2. Continue to roll thumbwheel until the middle shaft radiopaque marker band [5]
passes the proximal radiopaque markers of the stent resulting in full deployment,
or until the white activation arrow is visible on pull grip extension rod (for 150 mm
length stents), which indicates that pull grip activation is required to complete stent
deployment (Reference Figure 6). Long stents (150 mm) will not be fully deployed
by the thumbwheel alone.
Note: When activating the pull grip, avoid rapid deployment.
Note: Do not restrict movement of the thumbwheel [4] otherwise deployment
difficulties could be encountered. Do not attempt to pull a partially expanded stent
back into introducer/guide sheath as dislodgement may occur.
Note: Do not push or pull the delivery system during deployment as this may
compromise stent length.
Black (K) ∆E ≤5.0
Activation Arrow
Figure 6. Long stents (150 mm) require the pull grip to be retracted only after the
white activation arrow is visible to complete deployment.
3. Long stents (150 mm) require pull grip deployment after the white activation arrow
becomes visible on the pull grip extension rod. Grasp the manual pull grip [3] and
gently pull away from the handle in the direction of the arrow. Slowly pull back
until the middle shaft radiopaque marker band [5] passes the proximal radiopaque
markers of the stent resulting in full deployment.
4. View the delivery system under fluoroscopy, ensuring that the middle shaft
radiopaque marker band [5] has crossed the proximal stent markers. The delivery
system can now be withdrawn.
5. Grasp the guidewire a short distance from handle and repeatedly retract the
system over the wire until fully removed. Use caution when withdrawing the stent
delivery system and always manipulate under fluoroscopy. If unusual resistance is
felt, carefully readvance and rotate the delivery system in an attempt to center the
delivery system within the vessel, then carefully attempt to repeat withdrawal.
Note: Avoid bending the guidewire excessively near handle when retracting device
to aid removal and prevent guidewire kinking.
6. If incomplete expansion exists within the stent at any point along the lesion,
balloon dilatation can be performed utilizing standard PTA technique.
Precaution: Never post-dilate the stent using a balloon that is larger in diameter
than the nominal (labeled) diameter of the stent.
7. Withdraw guidewire and sheath from patient and establish hemostasis per
conventional technique.
10
MB Drawing 50573139 M