Precautions And Warnings - LeMaitre AlboGraft Mode D'emploi

• Graft disintegration
• Graft stenosis
• Pseudoaneurysm
• Intraluminal graft thrombus
• Perigraft air
• Respiratory failure

Precautions and Warnings

• Only one AlboGraft should be implanted in one patient during his/her lifespan.
• Device cannot be exposed to temperatures above 45°C (113°F). Excessive heat will seriously damage the
AlboGraft Polyester Vascular Graft and render it unfit for use.
• Do not use a prosthesis if the container and/or seal has been opened or damaged, or if the period of
sterility has expired.
• The collagen-impregnated graft must never be resterilized.
• Grafts contaminated with blood during the preceding procedures must not be re-used or resterilized.
• The vascular grafts must be handled so as to avoid contact with extraneous particles which, if they
adhere to the graft wall, may generate emboli or undesirable interactions with the blood. Furthermore,
surgical gloves used to handle grafts should not contain powders, preservatives or lubricants.
• Avoid overstretching the graft; gently expand the graft to smooth the folds.
• Avoid damaging the graft when handling, use atraumatic clamps and appropriate instruments (e.g.
vascular clamps). Avoid using these instruments with undue force, otherwise the collagen coating or
fabric will be damaged.
• Atraumatic needles are recommended.
• Low temperature ophthalmic cautery (≤ 704 °C/1300 °F) is recommended for cutting woven grafts to
avoid fraying.
• AlboGraft Removable Spiral Reinforcement Prosthesis (ASC Models)*: Avoid clamping the graft on its
reinforced area.
• AlboGraft Removable Spiral Reinforcement Prosthesis (ASC Models)*: Gently remove the support spiral,
otherwise the collagen film will be damaged.
• Care should be taken to ligate and/or cauterize lymphatics in the groin to minimize the occurrence of
seroma formation and lymphatic collection subsequent to aorto-femoral or femoropopliteal reconstruc-
tion.
• These prostheses should not be implanted in patients who exhibit sensitivity to polyester or materials of
bovine origin.
Re-sterilization/Repackaging
This device is single-use only. Do not reuse, reprocess, or re-sterilize. The cleanliness and sterility of the
re-processed device cannot be assured. Reuse of the device may lead to cross contamination, infection,
or patient death. The performance characteristics of the device may be compromised due to reprocessing
or re-sterilization since the device was only designed and tested for single use. The shelf life of the device
is based on single use only. If for any reason this device must be returned to LeMaitre Vascular, place it in
its original packaging and return it to the address listed on the box.
Conservation and Storage
The grafts must be kept in their original packaging until used. They must be kept in a dustfree and dry environ-
ment and at a temperature between 0 °C /32°F and 30 °C/ 86 °F.
Lifetime of the Graft
The lifetime of the AlboGraft Vascular Graft has been set at 10 years based on the following studies. Van Det
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• Chylothorax
• Temporary psychotic syndrome (includ-
ing transient delirium)
• Hemiparesis
• Visceral ischemia
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