Potential Complications - LeMaitre AlboGraft Mode D'emploi

Prothèse vasculaire en polyester

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is only internally sterile: it must not be brought into a sterile environment.

Warning: The AlboGraft Vascular Graft double container is provided in a vacuum sealed foil pouch.

This pouch protects the graft during storage and should be opened only immediately prior to use.

The labeling is color coded to identify the fabric characteristics and collagen impregnation of the model

contained inside (see table within "Available Models").

Instruction For Use

Choice and Preparation of the Graft

Choose the graft type and size best suited to the vascular section to be replaced or supplied through a bypass.

Carefully examine the double packaging enclosing the selected graft to verify its integrity, the absence of holes,

cuts or perforations, and the expiration date. The sterility of the graft is guaranteed only if the container is

perfectly intact. Make sure that the period of sterility has not expired, otherwise the sterility of the graft is not

guaranteed. Make sure that the information on the labels relative to the model, type, size, and lot number is

correct. If it is not, do not use the graft. Remove Tyvek lid from external container and introduce inner container

into sterile environment using aseptic procedures.

CAUTION: do not bring the external container into the sterile environment.

Remove the graft using an aseptic procedure.

Preparation Vascular Grafts

The collagen impregnated vascular grafts can be used as supplied or after immersing it in a sterile saline

solution just before implantation, to make them flexible and easy to handle. During the preparation and the

operation, care should be taken not to crush or excessively expand the graft. Correct handling helps avoid the

risk of damaging the collagen impregnation on the graft walls.

AlboGraft Removable Spiral Reinforcement Prosthesis (ASC Models)*

Cut the graft at the desired length. Remove the spiral support at the ends and cut close to the graft surface with

sharp surgical scissors in order to obtain the desired spiral free length to create the anastomosis, thus prevent-

ing the spiral support from interfering with suturing. Avoid clamping the graft on reinforced area.

Surgical Technique

Considering how complex a surgical implantation of vascular grafts is and how many factors can influence the

patient's condition, it is left to the surgeon to define suture technique and graft type as well as the therapy to

adopt before, during and after the operation.

The following precautions should; however, be considered:

• for suturing, cylindrical needles are recommended; although taper cut or other cutting needles are not

contraindicated.

• for cutting the woven graft (ATC) low temperature ophthalmic cautery (≤ 704 °C/1300 °F) is recom-

mended to avoid fraying. If high temperature cautery (≥ 1204 °C/2200 °F) is used, it is recommended to

immerse woven prosthesis in sterile saline solution immediately prior to use, preventing focal burning

which may occur during cauterization. Do not allow the prosthesis to dry prior to cutting with cautery.

• should the surgical technique require the graft to be clamped, atraumatic clamps (preferably with a

piece of soft, or lined jaws) should be applied with the minimum force necessary.