InspireMD CGuard CRX0620 Gebrauchsanweisung Seite 3

• Use with bleedback control hemostatic valves is not recommended.
• The system is not compatible with guidewires or embolic protection devices larger than
0.014" wire (0.36 mm).
• The system must be used with a guiding catheter or sheath to maintain adequate support of
the guidewire or embolic protection device throughout the procedure.
• If resistance is met during introduction or delivery of the stent delivery system, or during
retraction of the outer sheath, the system should be carefully withdrawn and another system
used.
• When the catheter is in the body, it should be manipulated only under fluoroscopy.
Radiographic equipment that provides high quality images is needed.
• Do not attempt to pull a partially deployed stent back through the guiding catheter or sheath;
dislodgement of the stent from the delivery system may occur.
• Withdraw the stent system carefully if resistance is encountered during movement through
the sheath or during initial retraction of the sheath.
• The delivery system is not designed for use with power injection. Use of power injection may
adversely affect device performance.
• When more than one stent is required to cover the lesion or if there are multiple lesions, the
distal lesion should be stented first followed by stenting of the proximal lesion. Stenting in
this order obviates the need to cross the proximal stent for placement of the distal stent and
reduces the chance of dislodging stents that have already been placed.
• If overlap of sequential stents is necessary, the amount of overlap should be kept to a
minimum (about 5 mm). In no instance should more than 2 stents overlap.
6.4 Post-Implant – Precautions
• Care must be exercised when crossing a newly deployed stent with other interventional
devices to avoid disrupting the stent geometry and placement of the stent.
• In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
• When using a proximal protective device it is required to re-sheath the tip (re-introduce the
tip back into the delivery sheath of the CGuard™ EPS) to ensure safe system retrieval into the
proximal protective device working channel.
7 MRI Safety Information
MR Conditional
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Non-clinical testing and MRI simulations were performed to evaluate the entire family of the
CGuard Carotid Stent. Non-clinical testing demonstrated that the entire family of the CGuard
Carotid Stent is MR Conditional. A patient with an implant from this family can be scanned safely
in an MR system under the following conditions:
• Static magnetic field of 1.5-Tesla and 3-Tesla, only
• Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/
kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode
Under the scan conditions defined, the CGuard Carotid Stent is expected to produce a maximum
temperature rise of 5.0˚ C after 15-minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the CGuard Carotid Stent extends
approximately 5-mm from this device when imaged with a gradient echo pulse sequence and a
3-Tesla MR system. The lumen of the CGuard Carotid Stent cannot be visualized on the gradient
echo or T1-weighted spin echo pulse sequences.
8 POTENTIAL ADVERSE EVENTS
Based on the literature and on clinical and commercial experience with carotid stents and
embolic protection systems, the following list includes possible adverse events associated with
these devices:
• Abrupt closure
• Acute myocardial infarction
• Allergic reaction (contrast medium; drug; stent or filter material)
• Amaurosis fugax
• Aneurysm or pseudoaneurysm in vessel or at vascular access site
• Angina Coronary ischemnia
• Arrhythmia (including premature beats, bradycardia, atrial and/or ventricular tachycardia,
atrial and/or ventricular fibrillation [VF])
• Asystole or bradycardia requiring placement of a temporary pacemaker
• Arteriovenous fistula
• Bleeding complications from anticoagulant or antiplatelet medication requiring transfusion
or surgical intervention
• Cerebral edema
• Cerebral hemorrhage
• Cerebral ischemia
• Congestive heart failure (CHF)
• Death
• Detachment and/or implantation of a component of the system
• Dissection of blood vessel
• Distal embolic protection device thrombosis occlusion
• Emboli, distal (air, tissue, plaque, thrombotic material, stent)
• Emergent or urgent surgery (Carotid Endarterectomy [CEA])
• Emergent surgery to remove stent or distal embolic protection device
• Fever
• Hematoma at vascular access site, with or without surgical repair
• Hemorrhagic event, with or without transfusion
• Hyperperfusion syndrome
• Hypotension/Hypertension
• Infection, local or systemic including bacteremia or septicemia
• lschemia/ infarction of tissue organ
• Pain (head/neck)/ severe unilateral headache
• Pain at catheter insertion site
• Renal failure/insufficiency secondary to contrast medium
• Restenosis of vessel in stented segment
• Seizure
• Stent distal embolic protection device entanglement/ damage
• Stent distal embolic protection device collapse or fracture
• Stent malapposition/migration
• Stent thrombosis occlusion
• Stroke / cerebrovascular accident (CVA) / transient ischemic attack (TIA)
• Total occlusion of the carotid artery
• Vascular thrombosis/occlusion at puncture site, treatment site, or remote site
• Vessel dissection, perforation or rupture
• Vessel spasm or recoil
9 STENT SIZE DETERMINATION
• Careful stent sizing is important to successful stenting. A minimum "interference" fit of 0.5
mm between the vessel and the stent is recommended in order to achieve optimum sizing
and stent expansion of the self-expanding stent. For example, select a 6.0 mm stent to treat a
4.8 – 5.7 mm diameter vessel. Select a 7.0 mm stent to treat a 5.6 – 6.5 mm diameter vessel.
The mean percentage of foreshortening for all stent sizes is less than 6%. The shortest stent
length consistent with total lesion coverage is optimal. Should adequate coverage by one
stent be impossible, a second stent may be used.
• The Rx delivery system has a 135 cm working length and is compatible with 0.014"
guidewires. Sheaths and guiding catheters with a minimum inner diameter of 2.24 mm are
recommended.
WARNING: The CGuard EPS is contraindicated for use with lesions in the ostium of the common
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carotid artery.
WARNING: Appropriate sizing of the stent to the vessel is required to reduce the possibility of
stent migration.
10 MATERIAL REQUIRED
• 6F (ID> 2.24) vascular sheath or 8F (ID> 2.24) guiding catheter or sheath length should not
interfere with stent Rx delivery system requirements.
• Optional balloon dilatation catheter.
• Any carotid EPD with a 195 cm and 0.014" guidewire.
• Two to three syringes (10 -20 cc).
• One 3 cc syringe.
• 500 cc heparinized saline solution (sterile).
CAUTION: CGuard EPS is not compatible with guidewires or embolic protection devices larger
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than 0.014" (0.36 mm).
11 PRE-PROCEDURE
Patient preparation and sterile precautions should be the same as for any angioplasty procedure.
The placement of the carotid stent in a stenotic or obstructed carotid artery must be done in a
procedure room with angiography capabilities. Angiography should be performed to map out
the extent of the lesion and the collateral flow. Access vessels must be sufficiently patent or
sufficiently recanalized to proceed with further intervention.
12 INSPECTION PRIOR TO USE
• Remove the CGuard EPS Self-Expanding Stent with Rx Delivery System from its protective
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packaging. Lay the device flat. Take care not to kink the shaft of the Rx delivery catheter
system.
CAUTION: Carefully inspect the CGuard EPS to verify that the device has not been damaged in
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shipment. Do not use damaged equipment.
CAUTION: The Rx delivery system has an internal shaft. Take care to avoid unnecessary handling
which may kink or damage the delivery system. Keep the Rx delivery system as straight as
possible and the delivery handle stationary during deployment. Do not use if device is kinked.
• Inspect the Rx delivery system sheath to verify that it has not been damaged during Shipment
and that the stent does not overlap the proximal marker.
• Ensure that the stent is fully covered by the sheath.
CAUTION: Special care must be taken not to handle or in any way disrupt the stent on the delivery
system. This is especially important during delivery system removal from packaging, placement
over the distal embolic protection device wire and advancement through a hemostatic valve and
guiding catheter hub.
CAUTION: The stent on the Rx delivery system is intended to perform as a system. Do not remove
the stent from the delivery system as removal may damage the stent. If removed, the stent
cannot be put back on the Rx delivery system.
13 DELIVERY SYSTEM PREPARATION
CAUTION: Do not expose the CGuard™ EPS to organic solvents as structural integrity and/or
function may be impaired.
• For device flushing use a 3 cc syringe filled with hepranized saline solution, maintain positive
pressure until saline fluid drops are observed exiting the CGuard
process may take 30 seconds.
• Alternatively: Fill an indeflator with 20 ml heparinized saline. Connect the indeflator to the
CGuard EPS and maintain 5 atm pressure for 30 seconds, or until the system is flushed and
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fluid is observed exiting the CGuard EPS at the distal end.
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CAUTION: Ensure that CGuard EPS is fully flushed with heparinized saline prior to use. Do not
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use the CGuard EPS if flush is not visible exiting at the distal end of the sheath.
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CAUTION: Do not use contrast material while flushing.
Keep the device straight and flat to avoid kinking the shaft.
14 LESION PREPARATION
WARNING: Administer heparin dose sufficient to maintain an ACT of > 250 secs to prevent
thrombus formation on the devices.
CAUTION: Venous access should be available during carotid stenting to manage bradycardia and
or hypotension by a pacemaker placement or pharmaceutical intervention, if needed.
CAUTION: The CGuard EPS must be used with a guiding catheter or sheath to maintain adequate
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support of the 0.014" guidewire or embolic protection device throughout the procedure.
CAUTION: Use of bleedback control hemostatic valves is not recommended.
CAUTION: When catheters are in the body they should only be manipulated under fluoroscopy.
Radiographic equipment that provides high-quality images is needed.
WARNING: Maintain continuous flushing while removing and reinserting devices on the
guidewire or embolic protection device. Perform all exchanges slowly to prevent air embolism
or trauma to the artery.
• Place an embolic protection device or distal protective device
• If needed, pre-dilate the lesion with an appropriate size balloon dilatation catheter to a
minimum of 3.0 mm after the distal protection device is in place beyond the lesion. Note: If
no predilatation balloon is utilized, there must be a minimum luminal opening of 3.0 mm to
enable retrieval of the tip of the CGuard delivery system.
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• Maintain the embolic protection device stationary while withdrawing the balloon catheter.
15 PROCEDURE
• If lesion pre-dilatation has been performed, remove the balloon catheter and load the
delivery system onto the 0.014" (0.36 mm) guide wire.
CAUTION: Using a proximal protection device (with minimum ID of 2.12 mm) along with a power
injector for lesion visualization is not recommended, CGuard™ delivery system may move distally
from its position during injection.
CAUTION: The Rx delivery system is not designed for use with a power injector. Use of a power
injector may adversely affect device performance.
EPS at the distal end. This
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