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RX Accunet
Embolic Protection System
CAUTION
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. FAILURE TO OBSERVE ALL WARNINGS AND PRECAUTIONS MAY RESULT IN
COMPLICATIONS.
Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and
hazards commonly associated with carotid interventional procedures should use this device.
Refer to the instructions supplied with all interventional devices to be used in conjunction with the RX Accunet EPS for their intended uses,
contraindications and potential complications.
DEVICE DESCRIPTION
The RX Accunet Embolic Protection System (EPS) is comprised of a delivery system and two recovery catheters with different features to address
varying patient anatomies and clinical challenges.
RX Accunet Delivery System:
The RX Accunet EPS guide wire with filter basket is a single use, steerable 0.014" (0.36 mm) guide wire system that comes in 190 cm and 300 cm
lengths. Attached to the distal end is a filter basket made of a thin porous membrane supported by a metal basket (Figure 1). The purpose of the filter
basket is to capture and recover embolic material produced during interventional procedures. The RX Accunet EPS guide wire with filter basket is
delivered to the target site while contained within the delivery sheath. Once the filter basket is positioned at the target site, the delivery sheath is
retracted by peeling it away from the guide wire to allow for full expansion of the filter basket. Radiopaque markers are located on the guide wire,
filter basket and delivery sheath to aid in device positioning. Once the filter basket has been deployed, the wire may be used as a standard guide wire
to support the delivery and placement of endovascular devices such as balloon dilatation catheters and endovascular stents.
RADIOPAQUE MARKERS
INNER STOP
GUIDE WIRE CHASSIS
PROXIMAL BUSHING
(RADIOPAQUE)
GUIDE WIRE AND FILTER BASKET
RADIOPAQUE MARKERS
INNER STOP
GUIDE WIRE CHASSIS
PROXIMAL BUSHING
(RADIOPAQUE)
GUIDE WIRE AND FILTER BASKET (90º ROTATED)
FIGURE 1 - Guide Wire and Filter Basket
Filter Sizing Recommendation
Filter size selection is based on reference vessel diameter in the area where the filter basket will be expanded. Measurements of reference vessel
diameters may be acquired through:
•
Angiogram (Fluoroscopy)
•
Quantitative Coronary Angiography (QCA)
Filter Size
Fully Expanded
4.5 mm
5.5 mm
6.5 mm
7.5 mm
RX Accunet Recovery Catheter - "Shapeable Tip Design"
The RX Accunet Recovery Catheter is a rapid exchange (RX) catheter used to remove the RX Accunet EPS guide wire with filter basket from the
vasculature and guiding catheter / sheath while retaining any emboli or particulates collected in the filter basket during the procedure.
The RX Accunet Recovery Catheter has a shapeable tip that is designed to provide torqueability or steerability to the tip of the device.
The RX Accunet Recovery Catheter is available in four sizes and is compatible with the matching four sizes of RX Accunet Filter Baskets.
RX Accunet 2 Recovery Catheter - "Low-Profile, Flexible Design"
The RX Accunet 2 Recovery Catheter is a rapid exchange (RX) catheter used to remove the RX Accunet Embolic Protection System (EPS) guide wire
with filter basket from the vasculature and guiding catheter / sheath while retaining any emboli or particulates collected in the filter basket during
the procedure. The RX Accunet 2 Recovery Catheter has a lower profile and is more flexible than the RX Accunet Recovery Catheter.
In addition, the RX Accunet 2 Recovery Catheter has an extended soft tip and was designed to deflect away from stent struts without the need to
shape the distal tip. One size of RX Accunet 2 Recovery Catheter is used to capture all sizes of RX Accunet Filter Baskets.
HOW SUPPLIED
Sterile: Sterilized with electron beam radiation. Non-pyrogenic.
This single use device cannot be reused on another patient, as it is not designed to perform as intended after the first usage. Changes in mechanical,
physical, and / or chemical characteristics introduced under conditions of repeated use, cleaning, and / or resterilization may compromise the integrity of the
design and / or materials, leading to contamination due to narrow gaps and / or spaces and diminished safety and / or performance of the device. Absence
of original labeling may lead to misuse and eliminate traceability. Absence of original packaging may lead to device damage, loss of sterility, and risk of
injury to the patient and / or user.
Contents: Three pouches containing:
RX Accunet Delivery System: One (1) 0.014" (0.36 mm) guide wire with filter basket, One (1) delivery sheath, One (1) introducer tool,
One (1) torque device with peel away adapter, One (1) flushing tool.
RX Accunet Recovery Catheter – "Shapeable Tip Design": One (1) recovery catheter, One (1) catheter clip.
RX Accunet 2 Recovery Catheter – "Low-Profile, Flexible Design": One (1) recovery catheter, One (1) catheter clip.
Storage: Store in a dry, dark, cool place.
INDICATIONS
The RX Accunet EPS is indicated for use in patients undergoing percutaneous interventional procedures in carotid arteries to:
•
facilitate the placement of diagnostic and therapeutic devices during percutaneous interventional procedures
•
capture and remove embolic material that may be released during the procedure
EL2069693 (2015-07-31)
Page 2 of 53
RELEASED
RELEASED
(4 - PLACES)
OBTURATOR
GUIDE WIRE
TIP COIL
FILTER MEMBRANE
RADIOPAQUE
(4 - PLACES)
OBTURATOR
GUIDE WIRE
TIP COIL
FILTER MEMBRANE
RADIOPAQUE
Reference Vessel Diameter
Minimum to Maximum Range
3.25 to 4.0 mm
4.0 to 5.0 mm
5.0 to 6.0 mm
6.0 to 7.0 mm
Printed on : 01/21/2016
English
CONTRAINDICATIONS
The RX Accunet EPS is contraindicated for use in:
•
Patients in whom anticoagulant and / or antiplatelet therapy is contraindicated.
•
Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guiding catheter, sheath, embolic protection
system, or stent system.
•
Patients with known hypersensitivity to nickel–titanium.
•
Patients with uncorrected bleeding disorders.
WARNINGS
•
The safety and effectiveness of this device as an embolic protection system have not been established in vasculatures outside the carotid
arteries.
•
The safety and efficacy of the RX Accunet EPS have not been demonstrated with carotid stent systems other than the over-the-wire or
RX Acculink Carotid Stent System.
•
Appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure. Special consideration should be given
to those patients with recently active gastritis or peptic ulcer disease.
•
This device is intended for single-use only. Do not reuse. Do not resterilize, as this can compromise device performance and increase the risk of
cross contamination due to inappropriate reprocessing.
•
Do not use the product after the " Use By" date specified on the package.
•
Maintain the patient's Activated Clotting Time (ACT) > 250 seconds throughout RX Accunet EPS usage to prevent thrombus formation on the
device.
•
During positioning, advance the RX Accunet EPS guide wire with filter basket and the delivery sheath as a unit. Advancing the guide wire
independent of the delivery sheath may result in premature filter deployment.
•
Always advance or withdraw the RX Accunet EPS guide wire slowly using fluoroscopy to observe corresponding wire movement and tip
movement in particular. Never push, auger, retract or torque a guide wire that meets resistance. If the wire tip becomes entrapped within a
lesion or a device, such as a deployed stent, do NOT torque the guide wire. Determine the cause of resistance and take necessary remedial
action. Torquing or retracting the guide wire against resistance may damage the wire, cause wire tip separation, or cause vessel trauma.
Resistance may be felt and / or observed using fluoroscopy by noting any buckling of the guide wire tip.
•
Maintain continuous flush while removing and reinserting devices on the guide wire. Perform all exchanges slowly to prevent air embolism or
trauma to the artery.
•
Overstretching of the artery may result in rupture and life-threatening bleeding.
•
When introducing the delivery system, confirm that the wire tip is free within the vessel lumen and is not directed into the vessel wall. Failure
to do so may result in vessel trauma. Use the radiopaque marker on the interventional device to confirm position.
•
Avoid excessive movement of the RX Accunet EPS guide wire and filter basket during catheter device exchanges. Excessive movement of the
deployed basket may cause vessel trauma or spasm.
•
The filter basket must be kept distal to the area to be covered by the stent and proximal to the petrous portion of the carotid artery to avoid
excessive forces on the filter basket.
•
Allow for and maintain adequate distance between the radiopaque proximal bushing marker on the guide wire with filter basket and the stent
delivery system or other compatible interventional devices to avoid potential entanglement.
•
Always keep the open filter basket distal to the deployed stent. Do not attempt to pull an open filter basket through the stent. Do not attempt
to capture the filter basket by pulling it into the recovery catheter if the recovery catheter tip is in the stent area. Pulling the filter basket into
the stent area may lead to stent-filter basket entanglement and / or basket detachment. If filter basket entanglement or detachment occurs,
surgical conversion or collapsing the basket with a second stent should be considered.
•
Maintain proper guiding catheter / sheath support in the common carotid artery throughout the procedure. If guiding catheter / sheath access
cannot be maintained, the case should be discontinued. Failure to maintain proper support of the guiding catheter / sheath can lead to
prolapse of the catheter into the aortic arch, resulting in any of the following:
− Movement of an open filter through an undilated lesion; or
− Filter-stent entanglement, filter basket detachment and / or proximal movement of the stent; or
− Filter guide wire breakage.
•
Do not rotate either recovery catheter more than 90 degrees in either direction since this can result in the guide wire wrapping around the catheter.
•
Use with fixed (passive) hemostatic valves is not recommended.
•
If excessive debris is collected in the filter basket such that distal perfusion of dye is significantly reduced or no dye is perfusing past the filter,
the RX Accunet EPS may have reached its maximum capacity to contain emboli. Remove and replace the RX Accunet EPS. Otherwise it may be
difficult to completely recover all embolic debris and the potential for thrombus formation may increase.
•
Discard unused RX Accunet and RX Accunet 2 Recovery Catheters after completing procedure. Failure to discard unused recovery catheters can
result in any or all of the following: the use of a device past its "Use By" date; or the use of an incorrectly sized RX Accunet Recovery Catheter,
which can cause loss of particulates from the filter basket during recovery, filter-stent entanglement, filter basket detachment and / or
proximal movement of stent.
PRECAUTIONS
•
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide
wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage
and / or inaccurate torque response.
•
Do not expose the delivery or recovery systems to organic solvents (e.g. alcohol) as structural integrity and / or function of the device may be
impaired.
•
Confirm the compatibility of the RX Accunet EPS with the interventional devices before actual use.
•
To avoid air entrapment, do not leave the introducer tool in the valve while advancing the delivery system. Advance the delivery system slowly
through the guiding catheter / sheath.
•
Ensure that the torque device is secured tightly to the guide wire to avoid difficulties with deployment. If the torque device is not tightened
securely on the guide wire, proper deployment may not occur.
•
For proper positioning of the filter basket, the vessel distal to the lesion should have an absence of excessive tortuosity and be of adequate
length (approximately 4 cm distal to the lesion and proximal to the petrous portion of the vessel).
•
Reconfirm filter basket position prior to deployment of the stent to ensure that there is adequate distance between the radiopaque proximal
bushing marker on the guide wire with filter basket and the distal end of the desired stent position. Reposition the filter basket as necessary by
gently advancing the guide wire. Under fluoroscopy, observe movement of the filter basket to the desired position.
•
Observe all guide wire movement in the vessels using fluoroscopic guidance.
•
Venous access should be available during carotid stenting in order to manage bradycardia and / or hypotension by either pharmaceutical
intervention or placement of a temporary pacemaker, if needed.
•
The delivery system is not designed for use with power injection. Use of power injection may adversely affect device performance.
•
Do NOT deliver the RX Accunet EPS guide wire with filter basket through any interventional devices other than the RX Accunet EPS delivery
sheath.
•
Removal of the RX Accunet EPS guide wire with filter basket through any interventional devices other than the RX Accunet and the RX Accunet
2 Recovery Catheters has not been tested.
•
Care must be used when removing the filter basket through a newly deployed stent to maintain filter basket integrity and to avoid disrupting
the stent geometry.
•
If the RX Accunet EPS is desired for intervention in subsequent vessels, use a new device.
POTENTIAL ADVERSE EVENTS
Based on the literature, and on clinical and commercial experience with the use of embolic protection systems with a carotid stent, the following
alphabetical list includes possible adverse events associated with the use of this device:
•
Allergic reactions to antiplatelet agents / contrast medium
•
Aneurysm
•
Angina / coronary ischemia
•
Arrhythmia
•
Arterial occlusion / thrombosis at puncture site or remote site
•
Arteriovenous fistula
•
Bacteremia or septicemia
•
Bleeding from anticoagulant or antiplatelet medications
•
Cerebral edema
•
Cerebral hemorrhage
•
Cerebral ischemia / transient ischemic attack (TIA)
•
Congestive heart failure (CHF)
•
Death
•
Detachment and / or implantation of a component of the system
•
Emboli, distal (air, tissue, or thrombotic emboli)
•
Emergent or urgent endarterectomy surgery (CEA)
·
Fever
·
Filter thrombosis / occlusion
Any adverse event occurring involving the RX Accunet EPS should be reported immediately to Abbott Laboratories, Customer Service, at (951) 914-4669.
•
Groin hematoma, with or without surgical repair
•
Hemorrhage, with or without transfusion
•
Hypotension / hypertension
•
Infection and pain at insertion site
•
Ischemia / infarction of tissue / organ
•
Myocardial infarction (MI)
•
Pain (head, neck)
•
Pseudoaneurysm (femoral)
•
Renal failure / insufficiency
•
Restenosis of stented / dilated vessel
•
Seizure
•
Severe unilateral headache
•
Stent / filter entanglement / damage
•
Stroke / cerebrovascular accident (CVA)
•
Total occlusion of carotid artery
•
Vessel dissection, perforation, or rupture
·
Vessel Spasm or recoil
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