Contraindications - BIOTRONIK SMALL (S) Mode D'emploi

Description
The Orsiro Mission Sirolimus Eluting Coronary Stent System (herein-
after Orsiro Mission) is a drug-eluting balloon-expandable stent that
is pre-mounted on a rapid-exchange PTCA catheter delivery system
with a usable catheter length of 140 cm. There are two stent config-
urations: small and medium. Their respective diameters and lengths
are shown in the "Sizes" table.
The stent is made from a cobalt chromium alloy (L-605) and is
intended as a permanent implant. It is completely covered with a thin
layer of amorphous silicon carbide (referred to as proBIO coating).
The stent's abluminal, adluminal, and strut side-surfaces are coated
with BIOlute, a bioabsorbable drug matrix consisting of a drug
substance sirolimus and polymer poly-l-lactide (PLLA). The nominal
drug content of the stent is 1.4 µg sirolimus per mm². The stent is
positioned between two radiopaque markers on the distal end of the
delivery system which are used for fluoroscopic visualization.
The delivery system has a hydrophilic coating on the outer surface of
the distal shaft and a hydrophobic coating on the outer surface of the
proximal shaft.
The proximal shaft is a hypotube which begins within the hub and
extends to the guide wire exit port. There are two shaft markers on
the hypotube - 92 cm (brachial access) and 102 cm (femoral access)
from the distal end of the delivery system - to help monitor when the
delivery system tip exits the guiding catheter.
The delivery system has a coaxially-arranged lumen design consisting
of an outer inflation lumen and an inner guide wire lumen. The outer
inflation lumen is connected through the luer port on the hub. The
inner guide wire lumen starts at the tip of the delivery system and
ends at the guide wire exit port which is 29 cm from the distal end of
the delivery system.
The stent system is compatible with guide wires with a diameter of
0.014" (0.36 mm) and guiding catheters with an inner diameter of
≥0.056" (1.42 mm).
How Supplied
Sterile. Non-pyrogenic. Device is sterilized with ethylene oxide.
Contents
• One Stent System and one Compliance Chart in a sealed, peel-open
pouch.
• One Instructions for Use manual including one Patient Implant Card.
Storage
Store protected from sunlight and keep dry. Store between 15°C (59°F)
and 25°C (77°F). Short-term storage temperature excursions between
10°C (50°F) and 40°C (104°F) are allowed.
Indications
Orsiro Mission is indicated for improving coronary luminal diameter
in patients with symptomatic ischemic heart disease due to discrete
de-novo stenotic lesions and in-stent restenotic lesions (length
≤ 40 mm) in the native coronary arteries with a reference vessel
diameter of 2.25 mm to 4.0 mm including the following patient and
lesion subsets:
• Acute Coronary Syndrome (ACS)
• ST-Elevation Myocardial Infarction (STEMI)
• Diabetes Mellitus (DM)
• Complex Lesions (B2/C)
• High Bleeding Risk (HBR)
• Long Lesions (LL) (e.g. ≥ 20 mm)
• Small Vessels (SV) (e.g. ≤ 2.75 mm)
• Multi-Vessel Disease (MVD)
• Male/Female
• Old Patients (e.g. > 65 y).

Contraindications

Orsiro Mission is contraindicated for use in patients with/who:
• A known hypersensitivity or allergy to the stent and/or stent coating
materials such as amorphous silicon carbide, PLLA polymer,
L-605 cobalt chromium alloy (including the major elements cobalt,
chromium, tungsten, and nickel), sirolimus or its derivatives.
• Cannot receive the recommended antiplatelet and/or anticoagu-
lation therapy.
• A lesion judged to prevent a complete inflation of an angioplasty
balloon or a proper placement of the stent or the stent system.
• Transplanted organs.
• Are unsuitable candidates for standard percutaneous coronary
intervention (PCI).
Furthermore, contraindications specific to drug-eluting stent
(DES) implantation and general coronary artery stenting should be
considered.
6
Orsiro_Mission_IFU_Version_A.indd 6
Warnings
English
• This device carries an associated risk of subacute thrombosis,
vascular complications
careful selection of patients is crucial (see "Patient Selection &
Individualization of Treatment" section). The long-term effects of
DES and the risks associated with these implants are unknown. The
limited availability of long-term clinical data should be considered
before making a risk/benefit assessment for the patient prior to
implantation.
• This device is designed and intended for single use only. DO NOT
resterilize and/or reuse this device. Reuse of a single-use device
creates a potential risk of patient or user infections. Contamination
of the device may lead to injury, illness, or death of the patient.
Cleaning, disinfection, and sterilization may compromise essential
material and design characteristics leading to device failure.
BIOTRONIK will not be responsible for any direct, incidental, or
consequential damages resulting from resterilization or reuse.
• DO NOT use the stent system if the outer package and/or inner
package are/is damaged or opened, or if any of the provided infor-
mation is obscured or damaged.
• DO NOT use the device after the Use by date indicated on the label.
• DO NOT attempt to remove or readjust the stent on the delivery
system as it may damage the stent, polymer system and/or lead
to stent embolization. The stent cannot be removed and placed on
another balloon catheter.
• DO NOT expose the stent system to organic solvents e.g. alcohol.
• DO NOT expose and/or suspend the stent within any liquid solution
on the sterile field prior to the preparation and the insertion as the
drug carrier coating may be susceptible to damage or premature
drug elution.
• Administer appropriate anticoagulant, antiplatelet and vasodila -
tion therapy to the patient (refer to the "Patient Selection &
Individualization of Treatment" and "Pre- and Post-procedure
Antiplatelet Therapy Recommendations" sections).
• Manipulate the stent system under angiographic guidance when it
is in the body.
• Use stents with a similar composition when multiple stents are
required to treat the lesion as the risk of corrosion increases when
stents of differing metals contact one another.
• Potential interactions of Orsiro Mission with other DES have not
been evaluated and should be avoided whenever possible.
• It is not advised to treat patients with chronic total occlusions or
poor flow distal to the identified lesion.
• DO NOT exceed the original diameter of the vessel proximal and
distal to the lesion when inflating the balloon to reduce the potential
for vessel damage.
• DO NOT exceed the rated burst pressure (RBP) indicated in the
Compliance Chart. Use of a pressure-monitoring inflation device is
mandatory to prevent over-pressurization.
• Use only an appropriate balloon inflation medium (e.g. 50:50
mixture by volume of contrast medium and saline). NEVER use air
or any gaseous medium to inflate the balloon.
• Subsequent restenosis may require repeat dilation of the arterial
segment containing the stent. The long-term outcomes following
repeat dilation of endothelialized stents are unknown.
• Use outside of the specified indications is prohibited. The use of DES
in patients and lesions outside the labeled indications may have an
increased risk of adverse events, including stent thrombosis, stent
embolization, myocardial infarction (MI), or death.
Precautions
General Precautions
• This device should only be used in medical facilities by physicians
thoroughly trained and experienced in performing vascular inter-
ventions, (including cases of life-threatening complications).
• If the stent system was removed prior to expansion, DO NOT
re-insert it as the stent and/or the delivery system may have been
damaged during the initial attempt to cross the lesion or during the
withdrawal (refer to the "Special Retrieval Techniques" section for
instructions).
• Stent thrombosis is a low-frequency event that current DES
clinical trials are not able to fully characterize. Stent thrombosis
is frequently associated with MI or death. In clinical trials with
sirolimus eluting coronary stents, differences in the incidence of
stent thrombosis observed with the DES when compared to bare
metal stents have not been associated with an increased risk of
cardiac death, MI, or all causes of mortality. Additional data from
a longer-term follow-up in randomized clinical trials with sirolimus
eluting coronary stents and analyses of DES-related stent throm-
bosis is expected and should be considered when making treatment
decisions as the data becomes available.
• The patient's exposure to the drug and polymer system is directly
related to the number of stents and the implanted stent length.
Handling Precautions
• Prior to the procedure, the stent system should be visually examined
to verify its functionality and to ensure that its size is suitable for the
and/or bleeding events. Therefore,
specific procedure for which it is to be used.
• Exercise care when handling the device to reduce the possibility of
disrupting the delicate placement of the stent on the balloon and
accidental breakage, bending, kinking of the stent system shaft.
Special care must be taken not to handle or in any way disrupt the
drug coating of the stent; handling is important when removing the
catheter from the packaging, placement over the guide wire, and
advancement through the rotating hemostatic valve adapter and the
guiding catheter hub.
• DO NOT hold the delivery system's distal shaft using the hypotube
fastener.
• Take care when removing the stent system from the protection ring
as forceful movements may dislocate the protector and the stent.
• When removing the protector, always pull at the very distal end of
the protector to avoid dislocation of the stent. DO NOT touch the
part of the protector over the stent.
• Avoid excessive manipulation of the stent during flushing of the
guide wire lumen. Special care must be taken not to handle
or disrupt the stent coating and the stent itself on the balloon.
Manipulation, such as rolling the mounted stent with your fingers,
may loosen the stent from the delivery system balloon and cause a
dislodgement. Should there be some movement of or damage to the
stent, DO NOT use it.
Stent Placement Precautions
If the stent system is unable to easily reach/cross the lesion, stop
the procedure and follow the instructions under the "Removal of an
Unexpanded Stent" subsection. To avoid causing damage to the stent/
coating and/or premature dislodgement of the stent from the balloon
or its centered positioning on the balloon:
• DO NOT apply negative pressure to the stent system at any time
prior to the placement of the stent across the target lesion.
• DO NOT apply excessive force while attempting to cross the lesion.
• DO NOT force the passage if any resistance is felt at any time during
lesion access. Determine the cause of resistance before proceeding.
• DO NOT attempt to move an unexpanded stent in and out through
the distal end of the guiding catheter.
• Ensure that the rotating hemostatic valve of the guiding catheter is
fully open when inserting and positioning the stent system.
For correct stent placement:
• DO NOT torque the catheter more than one full turn.
• Ensure that the guide wire exit port, 29 cm from the distal tip of
the delivery system, remains in the guiding catheter during the
procedure.
• DO NOT inflate the balloon if a vacuum cannot be held as this
indicates a leak in the delivery system. If a vacuum cannot be held,
follow the instructions under the "Removal of an Unexpanded
Stent" subsection.
• Consider that the placement of a stent has the potential to
compromise the side branch patency.
• Implanting a stent may lead to dissection of the vessel distal and/or
proximal to the stented portion and could cause an acute closure of
the vessel and require additional intervention (e.g. coronary artery
bypass grafting, further dilation, or placement of additional stents).
• DO NOT post-dilate the stent to more than the Maximum Diameter
for Post-dilation.
• Avoid barotrauma outside the stent margins during post-dilation.
• Additional expansion of a deployed stent may cause a flow limiting
dissection. This may be treated by implanting another stent. When
multiple stents are implanted, the ends should overlap slightly.
• When treating multiple lesions, the distal lesion should be initially
stented, followed by stenting of the proximal lesion. Stenting in this
order obviates the need to cross the proximal stent in placement of
the distal stent and reduces the risks for dislodging the proximal
stent.
• The use of brachytherapy treatment, mechanical atherectomy
devices (directional atherectomy catheters, rotational atherectomy
catheters) or laser angioplasty catheters to treat in-stent restenosis
is not recommended.
Stent/Delivery System Removal Precautions
• If an unusual resistance is felt at any time during the procedure
or when removing the stent/delivery system, refer to the "Special
Retrieval Techniques" section for the correct removal instructions.
Failure to follow these instructions may potentially result in loss of
or damage to the stent and/or delivery system components.
• Stent retrieval methods, such as the use of additional wires, snares
and/or forceps, may result in additional trauma to the coronary
vasculature and/or the vascular access site. Complications can
include bleeding, hematoma, or pseudoaneurysm.
06.06.2019 11:09:45