LeMaitre XenoSure Mode D'emploi page 4

Implantation
Cut and/or trim the XenoSure Biologic Patch to the desired shape. Any
excess XenoSure Biologic Patch material should be treated as biological
waste and discarded according to hospital procedure.
During implantation, irrigate the XenoSure Biologic Patch tissue frequently
with sterile physiologic saline to prevent drying. Visually examine both
sides of the XenoSure® Biologic Patch. If one side appears smoother,
implant the smoother surface so that it faces the blood fl ow.
Surgical Technique
It is beyond the scope of this Instructions for Use booklet to instruct the
surgeon in specifi c repair procedures. LeMaitre Vascular, Inc. assumes that
any surgeon performing the above operations has received adequate train-
ing and is thoroughly familiar with the pertinent scientifi c 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 fi xed bovine pericardial tissue is
unknown. The clinical advantages in using this material along with its
known characteristics must be weighed against its current undetermined
long-term durability.
Safe Handling and Disposal
If serious medical incidents should arise during use of this medical
device, users should notify both LeMaitre Vascular and the Competent
Authority of the country where the user is located.
This product contains no sharps, heavy metals or radioisotopes, and is
not infectious or pathogenic. No special requirements for disposal are
evident. Please consult local regulations to verify proper disposal.
Dispose storage solution according to local and federal regulations.
Solution should not be disposed using septic systems. If there are no
disposal restrictions, solution may be diluted and disposed in a sanitary
sewer system. For more information see: https://www.osha.gov/
Publications/glutaraldehyde.pdf
Packaging & shipping of explanted XenoSure:
Return of the shipment to LeMaitre Vascular depends on 3 crucial
questions:
1. Is the explant obtained from a patient with a known or presumed
pathogenic condition at the time of the explant?
2. Is the explant obtained from a patient that has a known treatment
history that involves therapeutic radionuclides within the last 6
months?
3. Has the clinician obtained consent from the patient for the sample
to be returned to the manufacturer for research purposes?
In the event that the response to question 1 or 2 is affi rmative,
LeMaitre Vascular does not provide adequate guidance for
shipment. THESE EXPLANTS SHOULD NOT BE RETURNED TO
LEMAITRE VASCULAR UNDER ANY CIRCUMSTANCES. In these cases,
the explant should be disposed according to local regulations.
For explants that do not have pathogenic or radiologic hazards, please
use the following:
Pre-explantation:
1. If possible, perform a CT or Ultrasound scan of the device to
document patency.
2. LeMaitre Vascular can accept clinical information that is
patient-anonymized. LeMaitre Vascular requests information
including:
a) The original diagnosis which resulted in use of the implant.
b) The patient's medical history relevant to the implant,
including the hospital or clinic at which the device was
implanted.
c) The patient's implant experience prior to implant
removal.
d) The hospital or clinic at which the explantation was
done, and date of retrieval.
Explantation:
1. Explanted XenoSure patches should be directly transferred to a
sealable container fi lled with a solution of alkaline buff ered 2%
glutaraldehyde or 4% formaldehyde prior to shipment.
2. Cleaning of explanted patches should be minimal if necessary.
Proteolytic digestion should not be used in any circumstances.
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3. XenoSure explants should not be decontaminated under any
circumstances. DO NOT autoclave the sample or use ethylene
oxide gas to decontaminate.
Packaging:
1. Explants should be sealed and packed in a manner that
minimizes potential for breakage, contamination of the
environment or exposure to those handling such packages
during transit. Material that is absorbent and is cushioning
should be selected for isolating the sealable container inside
the secondary packaging. Primary and secondary packaging
must then be packaged inside an outer package.
2. Explants in sealed primary containers should be labeled with
an ISO 7000-0659 Biohazard symbol. The same symbol should
be attached to the secondary packaging and to the outer
packaging. Outer packaging should also be labelled with Name,
Address and Telephone Number of Sender, and the statement,
"Upon discovery of damage or leakage, the package should be
isolated and sender notifi ed".
3. Packages prepared in the above manner may be shipped to:
LeMaitre Vascular
63 Second Avenue
Burlington, MA 01803
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.
These limitations do not apply to consumers in Australia or to the extent
they are precluded by local law in any other jurisdiction.
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