LeMaitre Flexcel 2020-01 Mode D'emploi page 3

In general, a carotid endarterectomy procedure is affected by several factors. These factors include the size and
disease state of the artery, the size of the shunt and the technique used to secure the shunt in the artery. Care should
be taken when securing the shunt in the artery. There are several common securing methods including vessel loops,
umbilical tape, ligatures, tourniquets and surgical clamps.
Suggested Insertion Techniques
Isolate the carotid arteries. Loops should be placed around the arteries and the incision made. Select an
appropriately sized shunt based on the relative size of the diseased artery. Insert the shunt into the artery.
NOTE: Care should be taken when inserting the shunt into the artery. An inappropriate size shunt may cause damage to
the vessel or cause plaque to dislodge from the vessel wall.
Using the surgeon's preferred method, secure the shunt in the artery. Perform the endarterectomy. When the
endarterectomy is complete, remove the shunt and close the incision using the surgeon's preferred method.
NOTE: The surgeon has the option to use the tether to aid in removing the shunt from the artery by grasping the loose end
of the tether and gently pulling up.
Storage Shelf Life
Store device in a dry, dark area away from from fluorescent lights, sunlight, and chemical fumes. The recommended
shelf life is printed on each package. Do not clean or resterilize a used device. Proper stock rotation should be
practiced. LeMaitre Vascular, Inc. does not make provisions for replacing or reprocessing expired product.
Resterilization/Re-use
This device is single-use only. Do not reuse, reprocess, or re-sterilize. The cleanliness and sterility of the re-processed
device cannot be assured. Reuse the device may lead to cross contamination, infection, or patient death. The performance
characteristics of the device may be compromised due to reprocessing or re-sterilization since the device was only
designed and tested for single use. The shelf life of the device is based on single use only.
Notices: Limited Product Warranty; Limitation of Remedies
LeMaitre Vascular, Inc. warrants that reasonable care has been used in the manufacture of this device. Except as explicitly
provided herein, LEMAITRE VASCULAR (AS USED IN THIS SECTION, SUCH TERM INCLUDES LEMAITRE VASCULAR, INC., ITS
AFFILIATES, AND THEIR RESPECTIVE EMPLOYEES, OFFICERS, DIRECTORS, MANAGERS, AND AGENTS) MAKES NO EXPRESS
OR IMPLIED WARRANTIES WITH RESPECT TO THIS DEVICE, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE
(INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE) AND HEREBY DISCLAIMS THE SAME. LeMaitre Vascular makes no representation regarding the suitability for
any particular treatment in which this device is used, which determination is the sole responsibility of the purchaser. This
limited warranty does not apply to the extent of any abuse or misuse of, or failure to properly store, this device by the
purchaser or any third party. The sole remedy for a breach of this limited warranty shall be replacement of, or refund of
the purchase price for, this device (at LeMaitre Vascular's sole option) following the purchaser's return of the device to
LeMaitre Vascular. This warranty shall terminate on the expiration date for this device.
IN NO EVENT SHALL LEMAITRE VASCULAR BE LIABLE FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, SPECIAL, PUNITIVE,
OR EXEMPLARY DAMAGES. IN NO EVENT WILL THE AGGREGATE LIABILITY OF LEMAITRE VASCULAR WITH RESPECT TO
THIS DEVICE, HOWEVER ARISING, UNDER ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, STRICT LIABILITY, OR
OTHERWISE, EXCEED ONE THOUSAND DOLLARS (US$1,000), REGARDLESS OF WHETHER LEMAITRE VASCULAR HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH LOSS, AND NOTWITHSTANDING THE FAILURE OF THE ESSENTIAL PURPOSE OF ANY
REMEDY. THESE LIMITATIONS APPLY TO ANY THIRD-PARTY CLAIMS.
A revision or issue date for these instructions is included on the back page of these Instructions for Use for the user's
information. If twenty-four (24) months has elapsed between this date and product use, the user should contact
LeMaitre Vascular to see if additional product information is available.
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