AtriCure AtriClip PRO245 User manual

P001089.C
AtriClip® LAA Exclusion System with
Preloaded Gillinov-Cosgrove® Clip
(PRO235, PRO240, PRO245, PRO250)
Instructions for Use
DESCRIPTION
The AtriClip LAA Exclusion System contains the Gillinov-Cosgrove LAA Clip
(Clip) for occlusion of the heart’s left atrial appendage (LAA). The Clip is
pre-loaded on a disposable Clip applier. The AtriClip LAA Exclusion System
with preloaded Gillinov-Cosgrove Clip does not contain natural rubber
latex components.
AtriClip LAA Exclusion System
ILLUSTRATION AND NOMENCLATURE
1. Handle 5. Gillinov–Cosgrove
LAA Clip
9. Left/Right
Articulation
2. Activation Lever 6. Clip Opening Jaws 10. Articulation Lock
3. Lever ReleaseTrigger 7. Shaft 11. DeploymentTab
4. End Eector 8. Up/Down Articulation
BEFORE USING PRODUCT READ THE FOLLOWING
INFORMATIONTHOROUGHLY
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, performed 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 other appropriate viewing technologies.
CONTRAINDICATIONS
1. Do not use this device as a contraceptive tubal occlusion device.
2. Do not use this device if the patient has a known allergy to Nitinol
(nickel titanium alloy).
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.
3. Donotuseontissuewhich, in the opinionofthesurgeon,would notbe
able to tolerate conventional suture materials or conventional closure
techniques (such as surgical stapling).
4. Carefully evaluate Clip position, tissue thickness, and tissue width
prior to Clip deployment. To determine appropriate Clip size, refer to
the Cosgrove-Gillinov 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.
6. Do not use on a LAA greater than 50mm when tissue is uncompressed.
7. Do not use this device if the patient has sensitivity to Nickel (nickel
titanium alloy).
8. Visually check for rust on the Applier jaws prior to use. The Applier
should not be used for durations longer than 1 hour to prevent the
formation of rust.
PRECAUTIONS
1. Read all instructions carefully for the AtriClip LAA Exclusion System.
Failure to properly follow instructions may result in improper
functioning of the device.
2. Use of the device should be limited to properly trained and qualied
medical personnel.
3. Note that variations in specic procedures may occur due to individual
physician techniques and patient anatomy.
4. Donotdropor tossthedeviceasthis mayinducedamagetothe device.
If the device is dropped, do not use. Replace with a new device.
5. DO NOT RESTERILIZE. The AtriClip LAA Exclusion System is provided
STERILEandisintendedfor SINGLE use only.Re-sterilizationmaycause
loss of function or injury to patient.
6. 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.
7. Do not modify this instrument. Use of a modied device may result
in improper instrument function. AtriCure, Inc. makes no claim or
representation as to the performance characteristics of this product
if any modications have been made to the AtriClip LAA Exclusion
System.
8. Do not kink or excessively bend the shaft as this may aect device
performance.
9. Evacuate thrombusfromtheLAA 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.
10. Positionand deployClip ina mannerthatprovidesclearvisualization of
all tissues being accessed. Poor visualization may result in suboptimal
placement.
11. Take care to minimize manipulation of the LAA and Clip after Clip
deployment.
12. It is recommended that the Clip be deployed in a dry eld.
13. Do not use the Clip in temperatures below 20°C. Application of the Clip
in temperatures below 20°C may aect device performance.
14. Do not attempt to articulate the End Eector while in the locked
position.Forceappliedwhileinthe lockedposition may cause damage
to the device.
INSTRUCTIONS FOR USE
Surgeon judgment, with the assistance of the Gillinov-Cosgrove Selection
Guide, should determine what size Clip to apply.
ClipSelection
1. Using the Gillinov-Cosgrove Selection Guide, to determine correct
selection of the Gillinov-CosgroveLAA Clip. Clip sizes arelocatedonthe
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. Usingsteriletechnique, removethe AtriClip LAA ExclusionSystemfrom
its packaging.
3. Using the Activation Lever on the handle, gently open and close the
Clip to assure proper function.
Caution: Do not open and close the Clip more than 3 times with the
activation lever prior to deployment.
Articulationof End Eector
4. By pushing down and pulling the Articulation Lock (10) backwards
(proximal), the End Eector (4) of the AtriClip LAA Exclusion System
may be manually articulated up and down and side-to-side by either
the articulation levers or pressing on the end eector. The Clip (5) and
End Eector (4) can articulate 30° left or right and 30° up or down to
take into account anatomical variations in the patient’s anatomy.
5. To lock the End-Eector (4) in position, press the Articulation Lock (10)
forward.
ClipPositioning
6. ManeuvertheLAA ExclusionSystemintothetargeteddissectionplane.
7. Gently open the Clip by squeezing the Activation Lever (2).

HANDLING INFORMATION: Gillinov-Cosgrove LAA Clip
MRI Safety Information
MR Conditional
Non-clinical testing demonstrated that the AOD1 (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 (40-
T/m)(extrapolated) or less
• Maximum MR system reported, whole body averaged specic
absorption rate (SAR) of 4-W/kg for 15 minutes of scanning (i.e.,
perpulsesequence)intheFirstLevelControlledOperatingModeof
operation for the MR system
• Under the scan conditions dened for the AOD1 Clip is expected to
produce a maximum temperature rise of 2.9°C after 15-minutes of
continuous scanning (i.e., per pulse sequence).
Artifact Information
In non-clinical testing, the image artifact caused by the AOD1 Clip extends
approximately 10-mm from the AOD1 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
Rx ONLY Caution: Federal Law (USA)
restricts this device to sale by or on
the order of a physician
Lot Number
Attention, consult accompanying
documents
Follow instructions for use
Manufactured By
Not made with Natural Rubber
Latex
MR Conditional
Manufactured by:
AtriCure Incorporated
7555 InnovationWay
Mason, Ohio 45040 USA
Customer Service: 1-866-349-2342 (toll free)
513-755-4100
NOTE: The Clip automatically locks in the fully open position by means
of a Locking Trigger on the handle of the device. The lock can be
disengaged by pressing the Lever ReleaseTrigger (3).
8. Orient the Clip applier with pre-loaded Clip at the tip of LAA with the
loops at the ends of the Clip pointed away from the LAA.
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 axed 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. If the Clipis not placed correctly,gentlyopen theClip and reposition as
needed.
13. After the Clip is positioned correctly, grasp the Activation Lever (2) and
depress the Lever ReleaseTrigger (3) and slowly release the Activation
Lever allowing the Clip to close.
Deployment
14. Deploy the Clip by slowly pulling the Deployment Tab (11) at the
proximalendofthehandle. NOTE:TheDeploymentTab(11)withsteel
cables may be completely removed from the end of the Handle.
15. Unlock the end eector articulation (10) and carefully remove it from
the LAA as shown below leaving the Clip and attachment suture
behind.
Caution: After pulling the Deployment Tab, the AtriClip LAA Exclusion
System cannot be used to reposition the Clip.
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
shippingcontainers,properlabeling,andanRGAnumbermaybe obtained
from AtriCure, Inc.
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.