Contraindications - LeMaitre AnastoClip GC Instructions D'utilisation

A) 4007-06: Size M
The shape of the closed clip may vary according to tissue thickness.
The amount of Titanium that a patient is exposed to is
applier is implanted.
B) 4007-08: Size L
The shape of the closed clip may vary according to tissue thickness.
The amount of Titanium that a patient is exposed to is 92 milligrams per Applier if the entire load of the
applier is implanted.
C) 4007-09: Size XL
The shape of the closed clip may vary according to tissue thickness.
The amount of Titanium that a patient is exposed to is 140 milligrams per Applier if the entire load of the
applier is implanted.
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, 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.
3
2.3 mm 2.3 mm
1.1 mm
Approximate Span
3.3 mm
Before Closure
1.1 mm
1.7 mm
2.3 mm 2.3 mm
4.9 mm
1.1 mm
3.3 mm 2.5 mm
1.7 mm
2.3 mm 2.3 mm
Approximate Span Before
4.9 mm
Closure
1.1 mm
1.7 mm
2.5 mm
3.3 mm
1.7 mm
4.9 mm
2.5 mm
Approximate Span
Before Closure
2.5 mm
Approximate
Overall Length
2.3 mm
45 milligrams per Applier if the entire load of the
Approximate
Overall Length
3.3 mm
Approximate
Overall Length
4.9 mm
A
Clips Per Applier
35
B
Clips Per Applier
35
C
Clips Per Applier
25