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Surgical Technique
It is beyond the scope of this Instructions for Use booklet to instruct the surgeon in specific
repair procedures. LeMaitre Vascular, Inc. assumes that any surgeon performing the above
operations has received adequate training and is thoroughly familiar with the pertinent
scientific literature.
Clinical Experience
Bovine pericardial patches have been successfully used in intracardiac repair procedures for
the past 25 years with excellent clinical results. Published data on such use may be found in
medical literature.
At this time, the long term durability of fixed bovine pericardial tissue is unknown. The clini-
cal advantages in using this material along with its known characteristics must be weighed
against its current undetermined long-term durability.
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 RE-
SPECTIVE 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, CONSEQUEN-
TIAL, 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 Instruc-
tions 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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