LeMaitre LifeSpan ePTFE Mode D'emploi page 4

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 LifeSpan grafts 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.
3. LifeSpan 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:
Case History
Recovered Implants
LeMaitre Vascular, Inc. is extremely interested in obtaining recovered clinical specimens of LifeSpan ePTFE vascular grafts for analysis. A written report summarizing our fi ndings
will be provided upon completion of our evaluation. Please contact your local company representative for return of recovered grafts. The grafts should be placed in a solution of
10% formalin or 2% glutaraldehyde. Refrigeration is not necessary under these circumstances.
Limited Product Warranty; Limitation of Remedies
LeMaitre Vascular, Inc. warrants that reasonable care has been used in the manufacture of this device and that this device is suitable for the indication(s) expressly specifi ed in these
instructions for use. Except as explicitly provided herein, LEMAITRE VASCULAR (AS USED IN THIS SECTION, SUCH TERMS INCLUDE 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. 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.
These limitations do not apply to consumers in Australia or to the extent they are precluded by local law in any other jurisdiction.
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.
LeMaitre Vascular
Attn: Complaint Lab
63 Second Avenue
Burlington, MA 01803
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