LeMaitre AnastoClip GC Instructions D'utilisation page 4

Complications
• Infection
• Pain/swelling
• Tissue damage
• Blood leakage
• Hemorrhage
• Embolism
• Stenosis
• Intimal dissection
• Thrombosis/occlusion
Resterilization/Re-use
The applier is supplied sterile. The sterility of the device is assured as long as the packaging is not opened or damaged. The
entire device is considered to be non-pyrogenic. 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 of 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.
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.
Packaging and Shipping of Explanted AnastoClips:
Return of the shipment to LeMaitre Vascular depends on 2 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?
In the event that the response to question 1 or 2 is affirmative, 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:
LeMaitre Vascular can accept clinical information that is patient-anonymized.
LeMaitre Vascular requests information including:
1. The original diagnosis which resulted in use of the implant,
2. The patient's medical history relevant to the implant, including the hospital or clinic at which the device was implanted.
3. The patient's implant experience prior to implant removal.
4. The hospital or clinic at which the explantation was done, and date of retrieval.
Explantation:
1. Explanted AnastoClips should first be cleaned using one of the following:
a. Intense water rinse, followed by transfer to 70-80% ethanol, or
b. Cleaning in isopropanol with subsequent ultrasonic treatment, or
c. Cleaning in proteolytic enzyme solution, or
d. Cleaning in sodium hypochlorite solution (50-60 mg/l), or
e. Cleaning in 3% hydrogen peroxide.
2. Explanted AnastoClips should then be decontaminated with steam autoclaving or ethylene oxide.
3. AnastoClips should be packaged dry.
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. The sealed primary container should be placed
inside secondary packaging. Primary and secondary packaging must then be packaged inside an outer package, which
must be a rigid, fiberboard box.
2. The secondary packaging of cleaned, decontaminated AnastoClip explants should be labeled with an ISO 7000-0659
Biohazard symbol. Outer packaging should also be labelled with "Exempt human specimen" printed on a label with
dimensions at least 10 x 10 cm.
3. Shipping paper for the outer shipping container is not required.
4. Packages prepared in the above manner may be shipped to:
Notices: 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 specified in these instructions for use. 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. 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
4
• Anastomosis rupture
• Dehiscence
• Necrosis
• Seroma
• Anastomotic insufficiency
• Pseudoaneurysm
• Nerve injury
• Steal phenomenon
• Intimal hyperplasia
LeMaitre Vascular
63 Second Avenue
Burlington, MA 01803