Additional Instructions - Vascutek Thoraflex Hybrid Instrucciones De Uso

sterilisation 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 end-user.
6. Store in a clean, dry area at not less than 0°C and not more than 35°C.
7. Prostheses must be implanted within one month after removal from the foil pouch.
8. Clamping may damage any vascular prostheses. Atraumatic clamps, ideally with soft shod jaws, should be used
with a minimum application of force. Excessive force should be avoided as it will damage the polyester fibres and
the gelatin impregnation.
9. Excessive tension on the prosthesis should be avoided.
10. Round body taper point needles should be used when implanting these prostheses to minimize fibre damage.
11. If de-airing is required then the smallest possible needle should be used, 19 gauge is normally sufficient.
Hypodermic needles have a cutting point which may result in blood leakage and may require repair by suturing.
12. Devices should be selected according to the Vascutek Thoraflex Hybrid™ device sizing chart. The Vascutek
Thoraflex Hybrid™ device sizing chart has been devised using the internal vessel diameter (I.D.) measurements;
therefore no further calculations are required. If the outside vessel diameters (O.D.) are measured then an
allowance for the vessel wall thickness must be made before selecting a device from this table.
13. Long term performance of the graft has not been established, therefore patients should be monitored on a
regular basis for adverse events for example endoleaks and aneurysm growth.
14. The use of a balloon expandable stent, e.g. Palmaz stent, to treat an endoleak may result in abrasion of the
graft material leading to graft failure or fatigue.
15. Excess delivery system angulation will cause more kinking of the sheath and therefore require an increased
deployment force.
16. Delivery system removal - if the system is introduced around a curve it must be removed around that same
curve to avoid disruption to the graft or trauma to the vessel.
17. During use in dissection cases additional care must be taken during insertion and removal of delivery system
to minimise risk of trauma to vessel wall.
18. The Thoraflex Hybrid™ Device is a gelatin coated graft. Due to its use in conjunction with a delivery system the
graft may suffer some slight initial blood loss when compared to the use of a standard Gelweave graft

Additional Instructions

Initiation of Antegrade Perfusion: The bypass catheter should be placed in the side branch of the 4 Branch Plexus
and securely attached.
Completion of Antegrade Perfusion: Once bypass is complete, the cannula side arm of the 4 Branch Plexus should
be cut off and the remaining stump over-sewn using standard surgical technique.
Implantation
1. Preparation of Hybrid Prosthesis
The entire graft must be pre-soaked thoroughly for at least 1 minute in saline to ensure adequate absorption and
no longer than 5 minutes and shall not be allowed to dry out after soaking. Pre-soaking the stent graft will reduce
the unsheathing force.
2. Forming of Hybrid Prosthesis
The delivery system (Figure 2) can be formed to the anatomy of the aorta in the area of the stent graft only (Figure
3). DO NOT BEND WITHIN 10mm OF SPLITTER OR WHILE HOLDING HANDLE OF SYSTEM.
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