BIOTRONIK Astron Pulsar Instrucciones De Uso página 5

Description
The Astron Pulsar is a self-expanding stent pre-mounted on an over-
the-wire delivery system. The stent (1) is laser-cut from a Nitinol
tube. It carries 6 radiopaque extensions at each end (1a, 1b) and is
completely coated with amorphous silicon carbide (a-SiC:H). The
delivery system consists of two coaxially arranged elements: the inner
shaft (2) and the outer sheath (3).
The inner shaft is made of stainless steel proximally and thermoplastic
distally. The safety tab (4) that covers the stainless steel tube prevents
accidental stent release. The stainless steel tube incorporates a black
release marker (5) that indicates the completion of stent deployment
and ends with a Luer port (6) at the proximal guide wire exit. The central
guide wire lumen within the inner shaft continues to the radiopaque
tip (7). The stent is positioned on the inner shaft proximal to the tip,
between two radiopaque markers (8), which facilitate fluoroscopic
visualization, and positioning of the delivery system towards and across
the lesion. The outer sheath begins within the T-connector (9) and
extends towards the tip. It covers the stent and keeps it constrained
within its distal end. A hydrophobic coating is applied to the outside of
the inner shaft and the inside and the outside of the entire outer shaft.
The annular space between the inner shaft and the outer sheath can
be flushed through the Luer port (10) at the T-connector. The guide
wire lumen of the inner shaft is flushed through the Luer port at the
proximal guide wire exit. The guide wire lumen permits the use of
0.018" guide wires to facilitate advancement of the delivery system
towards and through the lesion to be treated.
The Astron Pulsar is shipped with an "Easy Release" tube (11) inserted
over the proximal outer sheath. The "Easy Release" tube is intended
to be inserted into the haemostatic valve of the introducer to reduce
friction between the delivery system and the haemostatic valve during
stent release.
Caution: Blood loss may be increased when the "Easy Release" tube
is used.
The stent delivery system and the "Easy Release" tube are compatible
with an appropriately sized introducer sheath according to the
indications on the label.
Caution: The label indicates minimum introducer sheath sizes. If
Astron Pulsar is used in conjunction with long and/or braided
introducer sheaths a larger French size than indicated on the
label may be necessary to reduce friction.
The stent is advanced to the intended implantation location by means
of the over-the-wire delivery system and is deployed by pulling back
the outer sheath at the T-Connector whilst immobilizing the inner
shaft. The stent remains in the vessel as a permanent implant.
How Supplied
Sterile. Non-pyrogenic. Device is sterilized with ethylene oxide.
Contents
• One (1) Astron Pulsar self-expanding stent system in a sealed, peel-
open pouch.
• One (1) Instructions for Use manual.
Storage
Store in a dark, dry location between 10°C and 30°C / 50°F and 86°F.
Indications
The Astron Pulsar self-expanding stent system is indicated for
use in patients with atherosclerotic disease of the femoral and
infrapopliteal arteries and for the treatment of insufficient results
after percutaneous transluminal angioplasty (PTA), e.g residual
stenosis and dissection.
Contraindications
Generally, contraindications to PTA are also contraindications for stent
placement. Contraindications include but are not limited to:
• Failed guide wire or balloon catheter access
• Highly calcified lesions resistant to PTA
• Lesions that prevent complete inflation of an appropriately sized
Angioplasty balloon
• Placement in the popliteal artery
• Large amounts of acute or sub-acute thrombus at the target lesion
• Perforated vessel
• Lesion that lies within or adjacent to an aneurysm
• Threatened occlusion of vital side branches
• Patients with uncorrected bleeding disorders and contraindication
for antiplatelets and/or anticoagulation therapy
IFU_Astron Pulsar LE Version G_ml.indd 5
• Patients with renal insufficiency or an allergy to contrast media
English
• Patients with an allergy to the coating compound (amorphous
silicon carbide)
Warnings
• This device is designed and intended for single use only. DO NOT
resterilize and/or reuse. Reuse of single-use devices 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.
• Use prior to the "Use by" date as specified on the label.
• Prior to the procedure, the stent system should be visually
examined to verify functionality and ensure that its size is suitable
for the specific procedure for which it is to be used.
• DO NOT expose the stent system to organic solvents, e.g. alcohol.
• When the stent system is in the body it should be manipulated while
under angiographic guidance.
• This device carries an associated risk of subacute thrombosis,
vascular complications and bleeding events. Therefore patients
should be carefully selected and antiplatelet therapy is
recommended for a period of 6 months post procedure.
• Precautions to prevent or reduce clotting should be taken. Flush
or rinse all products entering the vascular system with sterile
isotonic saline or a similar solution prior to use. The use of systemic
heparinization during the procedure is recommended.
• Stenting across a bifurcation could compromise future diagnostic or
therapeutic procedures.
• Never advance the delivery system without the guide wire extending
from the tip.
• Never advance a partially deployed stent proximally or distally. The
stent is not designed for dragging or repositioning.
• Once the stent is partially deployed it cannot be recaptured using
the stent delivery system.
• If strong resistance is experienced during manipulation, stop
the procedure and determine the cause of the resistance before
proceeding. If the stent cannot be deployed, the entire system
should be removed.
Precautions
• Only physicians thoroughly trained and educated in the
performance of percutaneous transluminal angioplasty (PTA) and
stent implantation should use this device.
• Exercise care during handling to reduce the possibility of releasing
the stent prematurely, accidental breakage, bending or kinking of
the catheter shaft.
• Use only guide wires with a 0.018" (0.46 mm) maximum diameter.
• Use only with an appropriately sized introducer sheath according to
the indications on the label.
• The delivery system is not designed for use with power injection
systems.
• Always keep the instrument filled with sterile heparinized isotonic
saline while it is in the vascular system.
• When treating multiple lesions the most distal lesion should be
stented first followed by the stenting of proximal lesions.
• When multiple stents are required to treat a lesion, stents should
be of similar composition as the risk of corrosion increases when
stents of differing metals contact one another.
• Recrossing a stent with adjunct devices must be performed with
caution.
• PTA and stent implantation are recommended only at hospitals
where emergency surgery can be performed immediately in the
event of a potential injury or life-threatening complication.
• The use of mechanical atherectomy devices or a laser catheter is
not recommended within the stented area.
• In vitro tests have shown that the silicon carbide coating strongly
reduces metal-ion release from the underlying Nitinol stent.
The possible clinical benefit for patients with allergies to Nitinol
compounds has not yet been established.
• If a large amount of thrombus is present in the vessel, alternative or
adjunctive strategies (mechanical debulking, thrombolysis, GPIIb/
IIIa inhibitors) must be considered.
• Disposal of packaging materials can be handled per normal
industrial/local standards. The used device shall be handled
according to hospital procedure.
• Fractures of Nitinol stents implanted in the superficial femoral
artery have been reported in the medical literature. Fractures
occurred more frequently and were more severe in long stented
segments and in the case of multiple, partially overlapping stents.
These fractures were frequently associated with restenosis or
occlusion of the artery.
Potential Adverse Events/Complications
Possible complications include, but are not limited to:
• Death
• Emergency surgery to correct vascular complications
• Embolization of air, thrombotic or atherosclerotic material
• Tissue necrosis and limb loss due to distal embolization
• Stent system events: Failure to deliver stent to intended site,
stent misplacement, stent deformation, stent embolization, stent
thrombosis or occlusion, stent fracture, stent migration, inadequate
apposition or compression of stent/s, withdrawal difficulties,
embolization of catheter material
• Vascular events: Access site hematoma, hypotension/ hypertension,
pseudoaneurysm, arteriovenous fistula formation, retroperitoneal
hematoma, vessel dissection or perforation, restenosis, thrombosis
or occlusion, vasospasm, peripheral ischemia, dissection, distal
embolization (air, tissue debris, thrombus)
• Bleeding events: Access site bleeding or hemorrhage, hemorrhage
requiring transfusion or other treatment
• Allergic reactions to contrast media, antiplatelets, anticoagulants,
amorphous silicon carbide
• Infection and sepsis
Directions for Use
It is recommended to pre-dilate the lesion using standard PTA
techniques before stenting. Remove the PTA balloon catheter from
the patient maintaining lesion access with the guide wire.
Stent Delivery System Preparation
Warning: Avoid manipulation of the stent release mechanism during
removal from packaging and flushing of the stent delivery system.
1. Select the appropriate stent size based on the diameter of the
artery adjacent to the lesion and the length of the segment to
be stented. The (unconstrained) stent diameter in relation to
the target artery reference diameter can be seen in the Stent
Size Selection Table below. The length of the stent should allow
overlap of the lesion by at least 5 mm on either side.
Stent Size Selection Table
Vessel Diameter Unconstrained Stent Diameter
2,5 - 3,5 mm
3,0 - 4,0 mm
4,0 - 5,0 mm
5,0 - 6,0 mm
2. After careful inspection of the pouch for damage to the sterile
barrier, peel open the pouch, and remove the tray. Carefully peel
open the lid, remove the stent delivery system and place it onto
the sterile field.
3. Examine the device for damage. Ensure that the stent is
contained within the outer sheath. Do not use if the stent is
partially deployed.
Flushing of the Stent Delivery System
4. Attach a 10 ml syringe filled with sterile heparinized saline to the
Luer port at the proximal guide wire exit and inject the saline into
the guide wire lumen until the fluid exits the catheter tip.
5. Attach a 10 ml syringe filled with sterile heparinized saline to
the Luer port of the sliding T-connector and vigorously inject
the saline until the fluid exits distally between the outer sheath
and the tip. Fluid may also be visualized at the Luer port at the
proximal guide wire exit.
6. Remove the syringe.
Introduction of the Stent Delivery System
7. Thread the distal tip of the stent delivery system over the proximal
end of the guide wire and advance the system until the wire exits
the Luer port at the proximal end of the delivery system. Take
care to keep the delivery system as straight as possible.
8. Carefully insert the stent delivery system through the introducer.
Caution: Verify that the distal end of the outer sheath is flush against
the tip. If a gap exists between the outer sheath and the tip,
carefully advance the outer sheath until it is flush against the tip.
9. Carefully advance the stent delivery system over the guide wire
towards the lesion to be treated.
4,0 mm
5,0 mm
6,0 mm
7,0 mm
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