Terumo Vascutek ePTFE, Instructions For Use Manual

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4. Clamping may damage any vascular
prosthesis. Atraumatic clamps, ideally with soft
shod jaws, should be used with a minimum
application of force on the unsupported section
of graft only. Excessive force must be avoided,
as it will damage the external support.
5. DO NOT PUNCTURE THE GRAFTS IN THE
SUPPORTED AREA, however it has been
demonstrated that this is not applicable for
ePTFE (Unity) supported grafts
5
.
6. Care must be taken not to puncture the
opposite side of the graft when suturing.
7. When using end supported and fully supported
grafts there will be less gelatin coverage under
the external support. After removing the support
the graft could behave more like unsealed
ePTFE. In such instances where suture holes
are placed within the peeled area the standard
implantation protocol should be deployed, eg.
use of haemostatic agents.
8. Use a non-cutting tapered needle with non-
absorbable monofilament polypropylene or
PTFE suture stitched a suitable distance from
the graft edge. To minimize suture line bleeding
pull the suture at an angle of 90° to the graft.
9. Store in a clean, dry area not less than 0°C
(32°F) and not more than 35°C (95°F).
10. PROSTHESES MUST BE IMPLANTED
WITHIN ONE MONTH AFTER REMOVAL
FROM THE FOIL POUCH.
11. Complications which may occur in conjunction
with the use of any vascular prosthesis include
but are not limited to: redundancy; infection;
ultrafiltration or perigraft seroma; thrombosis;
embolic events; occlusion; stenosis; mechanical
disruption or tearing of the suture line, graft
and/or host vessel; excessive suture hole
bleeding; formation of pseudoaneurysms due to
excessive, localized, or large needle punctures;
or perigraft haematomas.
Operative Technique
When implanting a Vascutek Ltd prosthesis,
select a bullet tipped tunneller suitably sized to
ensure that the graft will have a snug fit.
Wetting the graft in a sterile saline solution will
facilitate the passage of the graft through
the tunneller and optimize the handling
characteristics. Grafts should be immersed in
saline for no longer than 5 minutes and shall not
be allowed to dry out after soaking. See Figure
1 for recommended method.
This is not required for prosthesis rinsed in
Rifampicin. If rinsing a prosthesis in Rifampicin
prior to implantation Vascutek Ltd recommends
following the method as described in Figure 3.
Thrombectomy
Should a postoperative occlusion occur,
declotting can be performed by carrying out
a longitudinal incision with stay sutures for
thrombectomy procedures. When a transverse
incision is used, a horizontal mattress suture
technique may be required to aid closure.
Spiral Support
To remove the external spiral support from end
and fully reinforced Vascutek ePTFE grafts,
gently lift the end of the support with gloved
hands or atraumatic instruments. Unwind the
support by slowly peeling at a right angle to
the graft (Figure 2a). Rapid unwinding and/or
removal of the support parallel to the axis of
the graft may damage the product (Figure 2b).
In addition, the use of surgical blades or sharp
instruments to remove the support may damage
the graft.
Note: Centrally supported grafts have
approximately 6cm of spiral reinforcement. This
has NOT been designed for removal.
Figure 1 Standard Graft Soaking Procedure- For All Gelatin Sealed ePTFE Grafts
Standard operating room practice should be followed throughout this procedure to ensure that the sterility of the graft, and of
any other items involved, is not compromised.
Stage 1
Fill syringe
to 200ml
with warm
(37°C/98°F)
sterile saline.
Stage 2
Add saline solution
to the container,
taking care not to
damage the graft.
Rock the blister to
ensure complete
coverage of the
graft.
Stage 3
After 1-5 minutes
maximum, the graft can
be removed- excess
solution is allowed to
drain before the graft
is implanted. The graft
shall not be allowed to
dry out after soaking.