P001196.B
AtriClip® Flex•V™ LAA Exclusion System
with Preloaded V•Clip
(ACHV35, ACHV40, ACHV45, ACHV50)
Instructions for Use
PACKAGE CONTENTS
AtriClip Flex•V LAA Exclusion System
V Clip
RECOMMENDED ACCESSORIES
Gillinov-Cosgrove™ Selection Guide
DESCRIPTION
The AtriClip Flex•V LAA Exclusion System contains a V Clip for open
occlusion of the heart’s left atrial appendage (LAA).The Clip is pre-loaded
on a disposable Clip applier.The Flex•V LAA Exclusion System with
preloaded V Clip does not contain natural rubber latex components.
AtriClip Flex•V LAA Exclusion System
ILLUSTRATION AND NOMENCLATURE
1. V Clip 5. Shaft Rotation Knob
2. Clip Opening Jaws 6. Deployment Trigger
3. End Eector 7. Activation Lever
1
4. Shaft
1
The entire length of the shaft is malleable and intended for adjustments
up to 45 degrees in any direction.
BEFORE USING PRODUCT READ THE FOLLOWING
INFORMATION THOROUGHLY
IMPORTANT!
This booklet is designed to assist in using this product. It is not a reference
to surgical techniques.
INDICATION FOR USE
The AtriClip LAA Exclusion System is indicated for the occlusion of
the heart’s left atrial appendage, under direct visualization and in
conjunction with other cardiac surgical procedures.
Direct visualization, in this context, requires that the surgeon is able
to see the heart directly, with or without assistance from a camera,
endoscope, etc., or any other viewing technology.
CONTRAINDICATIONS
Do not use this device as a contraceptive tubal occlusion device.
WARNINGS
1. Do not attempt to reposition or remove the Clip after deployment.
This may result in tissue damage or tearing.
2. Use this device only as intended. Failure to do so may result in injury
to the user or patient.
3. Do not use on tissue which, in the opinion of the surgeon, would not
be able to tolerate conventional suture materials or conventional
closure techniques (such as surgical stapling). Doing so may result in:
tissue trauma, dehiscence, tissue tearing, displacement and/or lack of
desired homeostasis.
4. Carefully evaluate Clip position, tissue thickness, and tissue width
prior to Clip deployment. To determine appropriate Clip size, refer to
the Gillinov-Cosgrove Selection Guide Instructions for Use. Failure
to correctly size or deploy the Clip may result in: tissue trauma,
dehiscence, tissue tearing, displacement and/or lack of desired
homeostasis.
5. Do not use on a LAA less than 29mm in width and 1.0mm wall
thickness. Doing so may result tissue in: trauma, dehiscence, tissue
tearing, displacement and/or lack of desired homeostasis.
6. Do not use on a LAA greater than 50mm when tissue is
uncompressed. Doing so may result in incomplete occlusion of the
structure.
PRECAUTIONS
1. Federal Law (USA) restricts this device to sale by or on the order of a
physician.
2. Use of the device should be limited to properly trained and qualied
medical personnel.
3. Read all instructions carefully for the AtriClip Flex•V LAA Exclusion
System. Failure to properly follow instructions may result in improper
functioning of the device.
8. Handle
4. Note that variations in specic procedures may occur due to individual
physician techniques and patient anatomy.
5. Do not drop or toss the device as this may induce damage to the
device. If the device is dropped, do not use. Replace with a new
device.
6. DO NOT RESTERILIZE. The AtriClip LAA Exclusion System is provided
STERILE and is intended for SINGLE use only. Re-sterilization may
cause loss of function or injury to patient.
7. Carefully consider any pre-surgical treatment the patient may have
undergone and in corresponding selection of Clip size. Preoperative
radiotherapy may result in changes to tissue.These changes may, for
example, cause the tissue thickness to exceed the indicated range for
the selected Clip size.
8. Do not modify this instrument. Use of a modied device may result
in improper instrument function. AtriCure, Inc. makes no claim or
representation as to the performance characteristics of this product
if any modications have been made to the AtriClip Flex•V ™ LAA
Exclusion System.
9. Do not grasp device end eector to apply bend to shaft, as this may
result in damage to the device. Excessive bending or kinking of the
shaft may aect device performance. Do not attempt to twist the
device end eector, as this may cause damage to the device.
10. Evacuate thrombus from the LAA prior to Clip application as with
other conventional LAA occlusion surgical techniques. Evaluating for
the presence of thrombus should be done per the surgeon’s discretion
and standard of care.
11. Position and deploy Clip in a manner that provides adequate
visualization of all tissues being accessed. Poor visualization may
result in suboptimal placement.
12. Take care to minimize manipulation of the LAA and Clip after Clip
deployment.
13. It is recommended that the Clip be deployed in a dry eld.
14. Do not attempt to rotate the End Eector without pulling it out of the
locked position. Force applied while in the locked position may cause
damage to the device.
15. Only pull the deployment trigger when the clip is properly positioned
over the LAA. Pulling the Deployment Trigger permanently releases
the Clip from the applier.
INSTRUCTIONS FOR USE
Surgeon judgment, with the assistance of the Gillinov-Cosgrove Selection
Guide, should determine what size Clip to apply.
Clip Selection
1. Using the Gillinov-Cosgrove Selection Guide, to determine correct
selection of the LAA Clip. Clip sizes are located on the device package.
Clip Size LAA Size Range
35 mm 29 – 35 mm
40 mm 34 – 40 mm
45 mm 39 – 45 mm
50 mm 44 – 50 mm
2. Using sterile technique, remove the AtriClip Flex•V LAA Exclusion
System from its packaging.
3. Using the Activation Lever on the handle, gently open and close the
Clip to assure proper function.
Shaft Bending
4. The AtriClip Flex•V contains a malleable shaft of that may be reshaped
to aid in accessing the LAA. Apply gentle pressure to shape the device
shaft as required for anatomical variations.
Precaution: Do not grasp device end eector to apply bend to shaft,
as this may result in damage to the device. Apply bend by gently
concentrating force under both thumbs. Excessive bending or kinking
of the shaft may aect device performance. Do not attempt to twist
the device end eector, as this may cause damage to the device.
Shaft Rotation
5. By pulling the Rotation Knob forward (distal) and twisting it to the
left or right, the End Eector of the Flex•V LAA Exclusion System may
be manually rotated side-to-side. The Clip and End Eector can rotate
90° left or right in 45° increments to account for user preference or
variations in the patient’s anatomy.
6. To lock the End-Eector in position, release forward pressure on the
knob and ensure that it is seated into position.
Clip Positioning
7. Maneuver the AtriClip Flex•V LAA Exclusion System into the targeted
dissection plane.
8. Gently open the Clip by squeezing the Activation Lever.
NOTE: Maintain pressure on the Activation Lever in order to hold the Clip
open. This device does not contain an automatic locking function.
9. Gently position the Clip at the base of the LAA.
10. Position the Clip in a manner that provides clear visualization of all
tissues being accessed.
11. While the Clip is still axed to the Deployment Device, ensure that no
surrounding structures interfere with or are damaged by the Clip, and
that the Clip is placed correctly.
12. After the Clip is positioned correctly, slowly release the Activation
Lever allowing the Clip to close.
13. If the Clip is not placed correctly, gently open the Clip and reposition
as needed.
Deployment
14. Deploy the Clip by pulling the Deployment Trigger at the nose of
the handle. NOTE: An audible“click” will be heard when the
Deployment Trigger has been activated.
DISCLAIMER STATEMENTS
Users must assume responsibility for approving the condition of this
product before it is used. AtriCure, Inc. cannot be held liable for any
consequential damage, personal injury or damage to property nor for the
misuse of this product.
AtriCure, Inc. will not be liable for any damage caused by the reuse of
this product.
This Instruction for Use describes the procedures for proper use of the
product. Any deviation from these procedures, which may compromise
the function of the product, is the responsibility of the user.
HANDLING INFORMATION: V Clip
MRI Information
MRI Safety Information
MR Conditional
Non-clinical testing demonstrated that the AOD2 (Annular Occlusion
Device) clip is MR Conditional. A patient with this device can be scanned
safely in an MR system immediately after placement under the following
conditions:
• Static magnetic eld of 1.5-Tesla and 3-Tesla, only
• Maximum spatial gradient magnetic eld of 4,000-gauss/cm (40T/m)(extrapolated) or less
• Maximum MR system reported, whole body averaged specic
absorption rate (SAR) of 4-W/kg for 15 minutes of scanning (i.e.,
per pulse sequence) in the First Level Controlled Operating Mode of
operation for the MR system
• Under the scan conditions dened for the AOD2 Clip is expected to
produce a maximum temperature rise of 3.1°C after 15-minutes of
continuous scanning (i.e., per pulse sequence).
Artifact Information
In non-clinical testing, the image artifact caused by the AOD2 Clip
extends approximately 20-mm from the AOD2 Clip when imaged using a
gradient echo pulse sequence and a 3-Tesla MR system.
EXPLANATION OF SYMBOLS ON PACKAGE LABELING
Refer to the outer package label to see which symbols apply to this
product.
PYROGEN
Non-Pyrogenic
Sterilized by Gamma Radiation
Single Use Only
Expiration Date
Caution: Federal Law (USA) restricts
Rx ONLY
this device to sale by or on the order of a
physician
Lot Number
Precaution: Only pull the deployment trigger when the clip is properly
positioned over the LAA. Pulling the Deployment Trigger permanently
releases the Clip from the applier.
15. Carefully remove the End Eector from the LAA as shown below
leaving the Clip and attachment suture behind.
16. Discard the deployment device after use. Follow local governing
ordinances and recycling plans regarding disposal or recycling of
device components.
RETURN OF USED PRODUCT
If for any reason this product must be returned to AtriCure, Inc., a return
goods authorization (RGA) number is required from AtriCure, Inc., prior
to shipping.
If the product has been in contact with blood or body uids, it must be
thoroughly cleaned and disinfected before packing. It should be shipped
in either the original carton or an equivalent carton, to prevent damage
during shipment; and it should be properly labeled with an RGA number
and an indication of the biohazardous nature of the contents of shipment.
Instructions for cleaning and materials, including appropriate shipping
containers, proper labeling, and an RGA number may be obtained from
AtriCure, Inc.
Attention,
consult accompanying documents
Follow Instructions for Use
Manufactured By
Not made with Natural Rubber Latex
MR Conditional
Manufactured by:
AtriCure Incorporated
7555 I nnovation Way
Mason, Ohio 45040 USA
Customer Service:
1-866-349-2342 (toll free)
1-513-755-4100 (phone)
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