LeMaitre AnastoClip VCS Instructions D'utilisation page 2

AnastoClip® VCS Closure System
(Model Numbers e4000-05, e4000-06, e4000-07, e4000-08)
English — Instructions for Use
IMPORTANT!
This booklet is designed to assist in using the AnastoClip® VCS with titanium clips. It is not a reference
to surgical stapling techniques.
BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.
Indications
The AnastoClip applier has application in the repair of arteriovenous fistulae and the creation
of everting anastomoses in blood vessels and other small tubular structures. The Applier is also
intended for approximation of dural tissue (dural approximation is cleared only in the United States
and the European Union). Dural approximation is not cleared for Small appliers (e4000-05).
Effects
The AnastoClip applier is available in four (4) clip sizes: small-0.9 mm, medium-1.4 mm, large-2.0
mm and extra large-3.0 mm. The AnastoClip applier is also available in two (2) lengths: 2 in distal
shaft and 3 in. distal shaft. The AnastoClip VCS clip applier consists of a rotating shaft and an integral
cartridge containing titanium clips. The AnastoClip implantable clip is made of titanium and it is MRI-
Conditional (up to 3 Tesla). As the levers of the applier are squeezed together, the clip is closed around
the everted tissue edges. As the levers are released, a new clip is automatically loaded into the clip
applier jaws. It is recommended to use the Tissue Everting Forceps to aid in the everting of the tissue
edges and the AnastoClip remover for the removal of any clips (if necessary).
Schematic View And Nomenclature
A) Clips
B) Jaws
C) Shaft
D) Rotation Knob
E) Levers
F) Handle
Designs available (Table 1):
AnastoClip Applier
2" (5 cm) Shaft
3" (7.6 cm) Shaft
How Supplied:
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 for vascular applications.
The implantable clips, the stainless steel shaft and jaws of the applier are considered to be non-
pyrogenic for dura applications. The plastic part of the applier (handle, levers and
rotation knob) should not be in contact with cerebral spinal fluid.
Instructions For Use
NOTE: It is recommended to wear loupes. A 2.5X magnification is suggested.
1. Preparation of tissues is recommended as follows:
G) ARTERIOTOMY OR VENOTOMY: One optional stay suture at mid-incision.
H) END-TO-END: Horizontal mattress sutures at 3 and 9 o'clock.
I) END-TO-SIDE: Horizontal mattress sutures heel and toe: stay sutures at 3
and 9 o'clock.
J) SIDE-TO-SIDE: Horizontal mattress sutures at 12 and 6 o'clock: stay sutures
at 3 and 9 o'clock.
NOTE: Additional sutures may be placed depending on the length of the closure,
in order to facilitate a symmetrical eversion.
2. Symmetrically evert all tissue layers for secure nonpenetrating clip placement.
Evert the tissue edges of the vessel with the tissue everting forceps. Ensure
that all tissue edges are symmetrically everted prior to applying the clip.
Failure to symmetrically evert the tissue edges properly can result in possible
bleeding or leakage.
3. Inspect the tissue wall to ensure that the forceps do not damage tissue during
Small Medium
e4000-05
e4000-06
C
B
A
Large
e4000-07
1
G
1
G
I
I
2
2
5
D
E
Extra
Large
e4000-08
1
G
H
1
I
1
H
J
I
2
J
4
2
5
2
4
F
H
G
G
4
I
4
5
7