Disposal; Post-Procedure; Implantable Device Patient Information; Information To Brief The Patient - Boston Scientific ELUVIA Mode D'emploi

Disposal

To minimize the risk of infection or microbial hazards after use, dispose of device and
packaging as follows:
After use, device may contain biohazardous substances. Devices that contain
biohazardous substances are considered biohazardous waste and should be stored
in a biohazard container that is labeled with the biological hazard symbol. Untreated
biohazardous waste should not to be disposed of in the municipal waste system.
Biohazardous substances should be removed via Incineration prior to disposal.
Alternatively, biohazardous waste may be disposed of utilizing a certified facility for
biohazardous waste for proper treatment in accordance with hospital, administrative,
and/or local government policy.

10.11 Post-Procedure

Assess patient for hematoma and/or other signs of bleeding at the puncture site.
Determine appropriate antiplatelet therapy based on the Inter-Society Consensus
(TASC II) Guidelines recommendations (or other applicable country guidelines) for
antiplatelet therapy post-procedure to reduce the risk of thrombosis. Patients who
require premature discontinuation of antiplatelet therapy due to significant active
bleeding or the expectation of significant active bleeding should be monitored
carefully for cardiovascular and thromboembolic events and once stabilized have their
antiplatelet therapy restarted without unnecessary delay.
BSC is committed to long-term follow-up of ongoing studies to further support safety
and effectiveness of ELUVIA Drug-Eluting Stents.
Any serious incident that occurs in relation to this device should be reported to the
manufacturer and relevant local regulatory authority.

Implantable Device Patient Information

Advise the patient that additional information may be available to them on the
Boston Scientific website (www.bostonscientific.com/patientlabeling).

INFORMATION TO BRIEF THE PATIENT

The physician should consider the following points while counseling patients on the
use of ELUVIA in association with the interventional procedure:
• Discuss the risks and benefits including review of potential adverse events listed in
this document, both for ELUVIA and for other interventional treatments likely
to be employed.
• Discuss patient allergies in particular the risk for patients who may be allergic to
paclitaxel, polymer, nickel and/or titanium.
• Discuss the risks and benefits of antiplatelet therapy including risk of
thromboembolism should the patient be allergic or discontinue use.
• Discuss post-procedure instructions, including any follow-up appointments,
lifestyle changes, medications, and home-care or rehabilitation guidelines.
• Provide the patient with the completed implant card to carry and advise the patient
that additional information, including MRI conditions, may be available to the them
on the Boston Scientific website (www.bostonscientific.com/patientlabeling).
• Instruct the patient to present the implant card to their Healthcare professionals
(doctors, dentist, technicians) so they can take the necessary precautions.

Expected Lifetime

Inform the patient that the stent is a permanent implantable and has been tested
for structural integrity (fracture resistance) for a minimum of 10 years; however, the
materials of the device are nonbiodegradable and are intended to last for the lifetime
of the patient.
39 MB Drawing 50573139

REFERENCES

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

WARRANTY

For device warranty information, visit (www.bostonscientific.com/warranty).
ELUVIA is a registered trademark of Boston Scientific Corporation or its affiliates.
Magnetom Trio is a trademark of Siemens Aktiengesellschaft Corporation.
Syngo is a trademark of Siemens Aktiengesellschaft Corporation.
Intera is a trademark of Koninklijke Philips Electronics N.V. Corporation.
TAXOL is a trademark of Bristol-Myers Squibb Company.
Zilver PTX is a trademark of Cook Medical Technologies LLC.
All other trademarks are the property of their respective owners.
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Black (K) ∆E ≤5.0