Contraindications - LeMaitre AnastoClip GC Instructions D'utilisation

The shape of the closed clip may vary according to tissue thickness.
Warning
• SYMMETRICALLY EVERT ALL TISSUE EDGES
• PLACE CLIPS AS CLOSE AS POSSIBLE TO ONE ANOTHER
• AVOID USE ON VESSELS SEVERELY COMPROMISED DURING ENDARTERECTOMY
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. See figure below.
3. Place the clips in such a fashion that they are not "rocking" on their axis ("tips"). See figure below.
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 GC applier with tissue or prosthetic graft material (e.g., Meadox,
knitted polyester), ensure that the total thickness of the everted tissue to be anastomosed does not
exceed the total width of the clip being used (see tables A, B, and C).

Contraindications

1. Do not use the AnastoClip GC 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 clips should not be more than 0.5 mm between one another. If this cannot be achieved, use of
the AnastoClip GC applier is contraindicated.
3. Do not use the AnastoClip GC applier if all the tissue layers cannot be completely symmetrically
everted prior to application of the clip.
4. Do not use the AnastoClip GC 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.
6. The AnastoClip GC applier is not intended for use except as indicated. DISCARD AFTER USE. DO NOT
RESTERILIZE.
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