Handling And Storage; Operational Instructions; Inspection Prior To Use; Additional Items For Safe Use - Boston Scientific ELUVIA Mode D'emploi

Handling and Storage

Protect from light. Do not remove from carton until ready for use. Store at 25 °C (77 °F);
excursions permitted to 15 °C - 30 °C (59 °F - 86 °F).
The ELUVIA Drug-Eluting Stent is a nitinol stent that has an upper temperature limit of
55 °C (131 °F).
Precaution: Do not use if the temperature indicator dot on the carton or pouch is red
indicating that stent expansion may have been compromised.

10. OPERATIONAL INSTRUCTIONS

10.1 Inspection Prior To Use

Check the pouch for "Use By" date. Carefully inspect the sterile pouch before opening.
Do not use the product after the "Use By" date. If the integrity of the sterile package has
been compromised prior to the product "Use By" date (e.g., damage of the package),
contact your local Boston Scientific representative for return information. Do not use if
any defects are noted.

Additional Items for Safe Use

10.2 Recommended Materials (not included in stent system package)

• 0.035 in (0.89 mm) stiff guidewire of appropriate length (300 cm length
recommended for 130 cm length stent delivery systems)
• Introducer or guide sheath of appropriate size and length and equipped
hemostatic valve
• Luer lock syringe 10 ml (10 cc) for flushing the stent delivery system

Preparation

10.3 Patient Preparation

The percutaneous placement of a self-expanding stent in a stenotic or obstructed
artery should be done in an angiography procedure room with the appropriate
imaging equipment. Patient preparation and sterile precautions should be the same
as for any angioplasty procedure. Appropriate antiplatelet and anticoagulation
therapy must be administered pre- and post-procedure in accordance with standard
practices. Angiography should be performed to map out the extent of the lesion(s) and
the collateral flow. Access vessels must be sufficiently patent to proceed with further
intervention. If thrombus is present or suspected, thrombolysis should precede stent
deployment using standard acceptable practice.

10.4 Inject Contrast Media

Perform angiogram using standard technique.

10.5 Evaluate and Mark the Stenosis

Observe fluoroscopically the most distal view of the stenotic or obstructed artery.
Obtain a road map image of the lesion area if necessary.

10.6 Select Proper Stent System

1. Measure the diameter of the reference vessel (proximal and distal to the lesion or
obstruction). Select a stent based on Table 2-2.
2. Measure the entire length of the actual lesion and select the proper length of the
stent(s) to be deployed. To help ensure adequate apposition, it is recommended
that the length of the stent be chosen so that the ends of the stent extend at least
5 mm beyond both ends of the lesion into healthy tissue.
Black (K) ∆E ≤5.0
Precaution: Should more than one stent be required to cover the lesion, allow for
at least 5 mm of stent overlap. It is generally recommended that the distal stent be
placed first.
Precaution: When multiple stents are required, if placement results in metal to
metal contact, stent materials should be of similar composition.
3. Estimate the distance between the lesion and the entry site to select the proper
stent delivery system length.

10.7 Preparation of Stent Delivery System

1. Open the outer box to reveal the pouch containing the stent delivery system.
2. Check the temperature exposure indicator on the pouch label to confirm that the
product has not been compromised. See Precautions section.
3. After careful inspection of the pouch looking for damage to the sterile barrier,
carefully peel open the pouch and extract the stent delivery system tray.
4. Carefully withdraw the stent delivery system from the tray by grasping the handle
of the delivery system.
5. Examine the stent delivery system for any damage. If it is suspected that the
sterility or integrity of the device has been compromised (i.e. kinking or missing
component), the device should not be used. The device should not be used if the
device is kinked, or if the thumbwheel lock is not attached.
6. Do not remove the thumbwheel lock [2] prior to deployment. Premature removal of
the thumbwheel lock may result in an unintended deployment of the stent.
7. Attach a 10 ml (10 cc) syringe filled with saline to the flushing luer [6] on the
handle. Apply positive pressure. Continue to flush until saline appears at the distal
end of the guidewire lumen. Remove the flushing luer [6] (by pulling the syringe or
by pulling flushing luer [6]) (Reference Figure 4).
8
MB Drawing 50573139 M