Device Description; Contraindications - maquet FUSION Bedienungsanleitung

FUSION Vascular Graft
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

DEVICE DESCRIPTION

FUSION Vascular Grafts are synthetic vascular grafts constructed of two layers. The inner layer is comprised of extruded, expanded
polytetrafluoroethylene (ePTFE). The outer layer is comprised of knit polyester (PET or Polyethylene Terephthalate) textile. These two layers are
fused together with a proprietary polycarbonate – urethane adhesive. See figure 1, below.
• Knit polyester textile outer layer is designed to promote tissue in growth.
• ePTFE inner layer is designed to offer similar long-term patency rates as standard ePTFE vascular grafts.
• FUSION Vascular Grafts also have longitudinal elasticity, which enhances conformability and reduces tension on the anastomoses.
• FUSION Vascular Grafts feature a GUIDELINE Stripe to facilitate proper graft alignment.
• Externally Supported FUSION vascular grafts have a removable, continuous spiral support coil to increase compression resistance and to
minimize kinking.
INTENDED USE/INDICATIONS FOR USE
FUSION Vascular Grafts are designed to repair or replace peripheral arteries.

CONTRAINDICATIONS

• FUSION Vascular Grafts should not be used as a coronary artery replacement, as cardiovascular patch material, or for soft tissue repair.
WARNINGS AND PRECAUTIONS
1. Grafts contaminated with blood or bodily fluids cannot be cleaned for reuse or resterilized.
2. STERILE – DO NOT RESTERILIZE – SINGLE USE ONLY
Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may
result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or
cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or death of the patient.
3. Use in patients with potential allergy to PTFE, Polycarbonate Urethane or Polyester (polyethylene terephthalate) is not recommended.
4. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
PRECAUTIONS
GENERAL PRECAUTIONS (associated with device)
1. As with all grafts constructed of ePTFE, handling techniques are important to minimize the potential for perigraft seroma. Avoid exposure to
organic solvents (e.g. Betadine, alcohol), pressurized irrigating solutions, excessive contact with body fluids or blood prior to implant. Avoid
excessive manipulation. Clean gloves should always be used to avoid contamination and damage to the graft.
2. To prevent excessive force on the graft, use of a sheath tunneler is required.
3. Do not attempt to preclot FUSION Vascular Grafts.
4. Only cut the graft with a sharp scalpel or scissors to produce a clean, smooth edge.
5. If the textile layer of the FUSION Vascular Graft becomes excessively frayed, that portion of the graft should be re-trimmed.
6. Avoid excessive tension on the graft. The graft should be cut to the length required and should be implanted in a relaxed fashion. Failure to cut
the graft to an appropriate length may result in anastomotic disruption, excess anastomotic bleeding, limb loss or even death.
7. Always create ample tissue pockets in the fascia to allow for a slight elongation of the FUSION Vascular Graft following re-establishment of
blood flow.
8. Avoid exposure of the graft to excessive heat (200°F / 93°C), open flames, laser or cautery.
PROCEDURE-SPECIFIC PRECAUTIONS
1. A small diameter tapered needle, with a noncutting edge, should be used when suturing to reduce the incidence of suture hole bleeding.
2. Use only appropriately sized, nonabsorbable, monofilament sutures for reconstructions. The anastomoses should be properly constructed to avoid
excessive tension between the graft and the host vessel. To minimize anastomotic bleeding, topical hemostatic agents may be used.
2
Figure 1.
Cross-sectional view of FUSION Vascular Graft
Knit Polyester Textile
Outer Layer
Proprietary
Polycarbonate –
Urethane Adhesive
ePTFE Inner Layer
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