How Supplied; Handling And Storage; Operational Instructions; Device Selection - Boston Scientific SYNERGY Mode D'emploi

• Restenosis of stented segment
• Stent deformation
• Stent embolization or migration
• Stent fracture
• Stent thrombosis/vessel occlusion
• Stroke/cerebrovascular accident/transient ischemic attack
• Total occlusion of coronary artery
• Vessel spasm
• Vessel trauma requiring surgical repair or reintervention
Adverse events associated with daily oral administration of everolimus (or potential adverse
events not captured above, that may be unique to the everolimus drug coating):
• Abdominal pain
• Acne
• Allergic/immunologic reaction to drug (everolimus or structurally related compounds) or
the polymer stent coating or its individual components (see Drug component Description)
• Anemia
• Coagulopathy
• Diarrhea
• Edema
• Hemolysis
• Hypercholesterolemia
• Hyperlipidemia
• Hypertension
• Hypertriglyceridemia
• Hypogonadism male
• Leukopenia
• Liver function test abnormal
• Lymphocele
• Myalgia/Arthralgia
• Nausea
• Pain
• Pneumonia
• Pyelonephritis
• Rash
• Renal tubular necrosis
• Sepsis
• Surgical wound complication
• Thrombocytopenia
• Urinary tract infection
• Venous thromboembolism
• Viral, bacterial, and fungal infections
• Vomiting
• Wound infection
There may be other potential adverse events that are unforeseen at this time.

How sUppLIeD

Non-pyrogenic.
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
Black (K) ∆E ≤5.0

Handling and storage

Keep dry and protect from light.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Store product in outer carton until ready for use.
DO NOT REMOVE FROM FOIL POUCH UNTIL READY TO USE.
THE FOIL POUCH IS NOT A STERILE BARRIER.
Do not store devices where they are directly exposed to organic solvents or ionizing radiation.
The foil pouch contains nitrogen gas (N

operatIonaL InstrUctIons

Device selection

Select device(s) with nominal stent length(s) and diameter(s) appropriate for the lesion.

Inspection prior to Use

Check foil pouch for "Use By" date. Carefully inspect the foil pouch and the sterile package
before opening. Do not use the product after the "Use By" date. If the integrity of the foil
pouch or 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.

Material required (not included in stent system package)

Quantity Material
1 Guide catheter with ≥ 0.056 in (1.42 mm) inner diameter
2-3 20-mL (cc) syringe
1000 u / 500 cc Normal heparinised saline
1 ≤ 0.014 in (0.36 mm) guidewire
1 Rotating hemostatic valve
1 Diluted contrast medium 1:1 with normal heparinised saline
1 Inflation device (with luer fitting)
1 Torque device (optional)
1 Pre-deployment dilatation catheter
1 Three-way stopcock
1 Appropriate arterial sheath

preparation

package removal

step action
1. Open the outer box to reveal the foil pouch and carefully inspect the foil pouch for damage.
2. Carefully open the foil pouch by tearing along the tear strip as indicated on the foil
pouch to access the sterile barrier package containing the stent delivery system.
3. Carefully inspect the sterile barrier package for damage.
4. Carefully peel open the sterile barrier using aseptic techniques and extract the stent
delivery system.
5. Carefully remove the stent delivery system from its protective tubing for preparation of
the delivery system. Do not bend or kink the device during removal.
6. Remove the product mandrel and stent protector by grasping the catheter just proximal
to the stent (at the proximal balloon bond site) and, with the other hand, grasp the stent
protector and gently remove distally.
7. Examine the device for any damage. If it is suspected that the sterility or performance
of the device has been compromised, the device should not be used.
Guidewire Lumen flush
step action
1. Flush stent system guidewire lumen with normal heparinised saline using the flushing
needle supplied for the Monorail™ Delivery System at the distal end.
8
) and desiccant as a storage medium.
2