Contraindications - LeMaitre AnastoClip Instructions D'utilisation

FAILURE TO OBSERVE THE ABOVE MAY CONTRIBUTE TO INTEROPERATIVE OR POST-OPERATIVE
(SEVERAL DAYS) FAILURE OF ANASTOMOSIS RESULTING IN SERIOUS PATIENT INJURY.
Cautions
1. Squeeze the levers together fully until a discernible click is felt. Failure to squeeze the levers
completely can result in clip malformation and possible bleeding or leakage.
2. Ensure that the tissue to be anastomosed fits completely within the confines of the jaws or bleeding
and leakage may result.
3. Place the AnastoClips in such a fashion that they are not "rocking" on their axis ("tips").
4. Inspect the anastomotic site to ensure proper application and that hemostasis has been achieved.
If bleeding is observed after application, additional clips or placement of manual sutures may be
necessary to complete hemostasis.
5. Do not evert the tissue by grasping one tissue edge with one pair of forceps and the other tissue
edge with another pair of forceps and pulling them together to evert and apply the clips. This may
result in asymmetrical eversion of tissue, which could result in possible bleeding or leakage.
6. Inspect the tissue wall to ensure that the forceps do not damage tissue during manipulation.
7. When using the AnastoClip applier with tissue or prosthetic graft material (e.g., Meadox, knitted
polyester) ensure that the total thickness of the everted tissue and graft material to be anastomosed
does not exceed 1.0 mm for the medium 1.4 mm clip applier, 1.6 mm for the large 2.0 mm clip
applier and 1.8 mm for the extra large 3.0 mm clip applier.

Contraindications

1. Do not use the AnastoClip applier if tissue can not be properly everted due to the presence of
arteriosclerotic or calcified material, or where the vessel has been severely compromised due to
endarterectomy (e.g., carotid or any other artery in this condition).
2. The AnastoClips should not be more than 0.5 mm between one another. If this cannot be achieved,
use of the AnastoClip applier is contraindicated.
3. Do not use the AnastoClip applier if all the tissue layers cannot be completely symmetrically everted
prior to application of the clip.
4. Do not use the AnastoClip applier on tissue that is too friable for use of sutures.
5. The tissue must comfortably fit within the confines of the jaws, or use of the instrument is
contraindicated.
Complications
• Infection
• Pain/swelling
• Tissue damage
• Blood leakage
• Hemorrhage
• Embolism
• Stenosis
• Intimal dissection
• Thrombosis/occlusion
• Anastomosis rupture
• Dehiscence
• Necrosis
• Seroma
• Anastomotic insufficiency
• Pseudoaneurysm
• Nerve injury
• Steal phenomenon
• Intimal hyperplasia
• Cerebrospinal fluid (CSF) leak
• Pseudomeningocele
• Neuropathic pain
• Spinal infarction
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 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.
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,