Contraindications; Cautions - Vascutek Thoraflex THP2224X100B Instrucciones De Uso

SECTION 1.3 CONTRAINDICATIONS
This device should not be implanted in patients who exhibit;
1. Sensitivity to Polyester, Nitinol, or materials of bovine origin.
2. Active infection.
SECTION 1.4 CAUTIONS
1. The vascular graft material is based on a woven structure and therefore must be cut with a cautery to minimise
fraying.
NOTE: IMMERSION OF THE DEVICE IN A SALINE SOLUTION IMMEDIATELY PRIOR TO USE WILL
PREVENT FOCAL BURNING WHICH MAY RESULT DURING
in a saline solution for at least 1 minute, but no longer than 5 minutes. The device must not be allowed to dry out
after soaking.
2. It is of particular importance that the stented section is pre-soaked as advised in section 3.1 as this will greatly
reduce the force required to deploy the device.
3. DO NOT PRECLOT. These devices contain a gelatin sealant and must not be pre-clotted.
4. DO NOT USE BEYOND THE INDICATED EXPIRATION DATE. The gelatin impregnation may not meet the
design specification after the expiration date.
5. DO NOT RESTERILISE. FOR SINGLE USE ONLY. Do not reuse, reprocess or re-sterilise. Reuse, reprocessing
or resterilisation may compromise the structural integrity of the device and/or lead to device failure which, in turn,
may result in deterioration of health or death of patients. Reuse, reprocessing or resterilisation 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 cool dry place out of direct sunlight.
7. The device must be implanted within one month after removal from the foil pouch.
8. Clamping may damage the prosthesis. 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 the device to minimise fibre damage.
11. If de-airing is required then the smallest needle possible should be used. A 19 gauge needle is normally
sufficient. Hypodermic needles have a cutting point which may result in blood leakage and require repair by
suturing.
12. Devices should be selected according to the Vascutek Ltd. Thoraflex™ Hybrid Device Sizing Chart (see
section 2).
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 following an identical
path in order to avoid moving the device or causing trauma to the vessel.
17. In dissection cases, additional care must be taken during the insertion and removal of the delivery system in
order to minimise the risk of trauma to the vessel wall.
18. The graft section of the Thoraflex™ Hybrid Device is made from gelatin sealed Gelweave™ polyester material.
Due to its use in conjunction with a delivery system, the graft section may suffer some slight initial blood loss when
compared to a standard gelatin sealed Gelweave™ graft.
19. IF A GUIDEWIRE WAS USED DURING THE DEPLOYMENT OF THE DEVICE IT MUST BE REMOVED
FROM THE DELIVERY SYSTEM BEFORE THE RELEASE WIRE IS REMOVED – See Section 3.5.3.
CAUTERISATION. The device must be immersed
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