LeMaitre LifeSpan ePTFE Mode D'emploi page 2

LifeSpan® ePTFE Vascular Graft
Instructions for Use – English
Product Description
The LifeSpan® ePTFE reinforced Vascular Graft consists of an expanded polytetrafl uoroethylene (ePTFE) base tube reinforced with a thin spirally wrapped ePTFE tape. The graft also
contains an orientation line.
The LifeSpan reinforced expanded PTFE stepped vascular graft also consists of an expanded polytetrafl uoroethylene (ePTFE) base tube reinforced with a thin spirally wrapped ePTFE
tape and an orientation line.
The LifeSpan expanded PTFE externally supported vascular grafts also consist of an expanded polytetrafl uoroethylene (ePTFE) base tube reinforced with a thin spirally wrapped ePTFE
tape and an orientation line. These grafts also have an external PTFE monofi lament support for increased crush and kink resistance.
Indications
• The LifeSpan ePTFE vascular grafts are indicated for use as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels,
or for arteriovenous shunts for blood access.
• The physician must evaluate each alternative method of treatment, discuss the risks and benefi ts with each patient, and decide whether to use a prosthetic vascular graft based
upon all available factors.
• Grafts with removable external monofi lament support over the length of the graft are used in bypass or reconstruction of occluded or diseased vessels, where compression or
kinking could jeopardize patency.
• Grafts with external monofi lament support in the middle of the graft may be used for the creation of an arteriovenous shunt for blood access; however, the graft must not be
cannulated in the area of the external monofi lament support.
• Stepped grafts are used for the creation of arteriovenous shunts for blood access. Stepped confi gurations may reduce the risk of steal syndrome and high cardiac output.
Contraindications
• The LifeSpan ePTFE vascular graft is neither indicated nor approved for use in coronary artery bypass procedures . Do not use the LifeSpan ePTFE vascular graft as a patch.
• LifeSpan ePTFE externally supported vascular grafts with external support along the entire graft length are not recommended for vascular access applications.
Warnings
For Single Use Only
1. Radiation should never be used for sterilization as this may damage the graft.
2. Do not expose the graft to either an open fl ame or to a laser without fi rst providing adequate ventilation, as temperatures in excess of 400°C (752°F) produce highly toxic
decomposition products.
3. Do not preclot the graft or immerse the graft in any solution (i.e. alcohol, oil, or aqueous solutions) prior to implantation. Exposing the graft to these solutions will aff ect the
hydrophobic properties of ePTFE, resulting in wetting and possible excessive seroma formation.
4. Do not force any solutions through the graft lumen when examining the anastomosis during surgery as this may aff ect its hydrophobic properties, resulting in possible seroma
formation.
5. Because the graft is not longitudinally elastic, the graft must be long enough to allow for a full range of body movements and to eliminate stress on the anastomoses.
6. Cut the graft with a sharp surgical instrument to avoid damage to the thin spirally wrapped ePTFE tape. Failure to correctly cut the LifeSpan ePTFE vascular graft may result in
aneurysmal dilatation or reduced suture retention strength.
7. Do not pull or peel the thin spirally wrapped ePTFE tape from any area of the graft.
8. Use only clean gloves and atraumatic clamps or guarded (i.e. rubber shod) clamps to prevent damage to the graft wall during implantation. Avoid repeated or excessive clamping
on any section of the graft.
9. Protect graft from damage by heavy or sharp objects.
10. When using a graft with removable external PTFE monofi lament support, slowly unwind the monofi lament at a right angle to the graft. Be careful to avoid removal of the thin
spirally wrapped ePTFE tape. Rapid unwinding and/or removal of the monofi lament support parallel to the axis of the graft may damage the product.
11. Externally supported grafts used for arteriovenous shunts for blood access must not be cannulated in the area of the external monofi lament support.
Surgical Precautions
Cutting
• Before cutting the graft, gently pull the graft taut and determine the correct length. The patient's body weight and posture must be considered as well as the anatomical
location of the graft. It is especially important that the graft be cut long enough for axillofemoral, axillobifemoral, femorofemoral bypass or any other extraanatomic
procedures.
• After adequate control of the distal vessel is achieved, use a new knife blade to make a longitudinal incision in the artery at the site of anastomosis. Utilize sharp scissors to
cut one end of the ePTFE graft at a bevel to obtain an opening equal to the length of the arteriotomy.
• When cutting the graft, a sharp surgical instrument must be used to prevent damage to the thin spirally wrapped ePTFE tape. If the thin spirally wrapped ePTFE tape
becomes frayed after cutting the graft, trim that portion of graft with a sharp surgical instrument. The thin spirally wrapped ePTFE tape should never be pulled or peeled
away from any portion of the graft. Removal of this outer layer could result in aneurysmal dilation or a reduction in suture retention strength.
Tunneling
• Use a tunneler to create a tissue tunnel that closely approximates the graft diameter. An oversized tissue tunnel may result in delayed or insuffi cient perigraft tissue
attachment and may promote perigraft seroma formation.
• Extreme care should be taken to prevent kinking of the graft when passing it through tunnels.
• When creating a tunnel for the LifeSpan ePTFE externally supported grafts, make the tunnel one to two millimeters larger than the internal diameter of the graft being
implanted to allow free passage of the external monofi lament support.
Suture Technique
Disruption of the graft, host vessel, and/or suture lines may occur if appropriate suture techniques are not observed.
• Utilize a small diameter, tapered, noncutting needle to prevent bleeding from suture holes. A full-radius cutting needle may damage the graft and should not be used.
• During anastomosis, use appropriate suture placement and small equal bites and avoid undue tension on the suture line.
• Following completion of the distal anastomosis, the graft should be gently fi lled and fl ushed with heparinized saline solution until circulation is restored. Be careful not to
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