Indications For Use; Contraindications; Warnings And Precautions; Patient Selection, Treatment, And Follow-Up - Medtronic Endurant Manual Del Usuario

2011/DEC/22 at 7:46 p.m. Doc number: M716803B001 [multi23]
1.3.2. Endurant Iliac Delivery System
The Endurant Iliac Delivery System (Figure 7) is constructed of three concentric single lumen shafts (an
outer hydrophilic coated polymer graft cover, a middle member polymer shaft, and a guidewire lumen
containing stainless steel inner member). A stent stop is attached to the distal end of the middle member
shaft to maintain the position of the contralateral (or other) limb component during deployment. A
polymeric, atraumatic tapered tip is attached at the distal end of the inner member to facilitate tracking
through tortuous and calcified vessels. The taper tip, stent stop, and ring marker on the distal end of the
graft cover are radiopaque and aid in fluoroscopic visualization. The deployment of the self-expanding
stent graft components is facilitated by the retraction of the graft cover. Post-deployment of the stent graft
component, the tip of the delivery system should be retracted into the graft cover before removing the
delivery system from the body.
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1. Rear Handle
2. Screw Gear
3. External Slider
4. Front Grip
Note: Graphic representation not to scale

2. Indications for Use

The Endurant Stent Graft System is indicated for the endovascular treatment of infrarenal abdominal aortic
or aorto-iliac aneurysms having:
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Adequate iliac/femoral access
•
Short and angulated proximal neck aneurysms with neck diameters of 19 mm through 32 mm
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Iliac diameters of 8 mm through 25 mm
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Proximal necks ≥ 10 mm in length with non-significant calcification, and/or non-significant
thrombus with ≤ 60° infrarenal and ≤ 45° suprarenal angulation and a vessel diameter
approximately 10–20% smaller than the labeled Endurant Stent Graft diameter
•
Proximal necks ≥ 15 mm neck with non-significant calcification, and/or non-significant thrombus
with ≤ 75° infrarenal and ≤ 60° suprarenal angulation and a vessel diameter approximately
10–20% smaller than the labeled Endurant Stent Graft diameter
•
Morphology suitable for endovascular repair
•
Distal fixation length of ≥ 15 mm
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One of the following:
aneurysm diameter > 5 cm
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aneurysm diameter of 4–5 cm which has also increased in size by 0.5 cm in the last 6 months
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aneurysm which is at least 1.5 times the diameter of the normal infrarenal aorta
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3. Contraindications

There are no known contraindications currently associated with the Endurant Stent Graft System.

4. Warnings and Precautions

4.1. General
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The long term safety and effectiveness of this implant has not been established. All patients with
endovascular aneurysm repair must undergo periodic imaging to evaluate the stent graft,
aneurysm size, and occlusion of vessels in the treatment area. Significant aneurysm enlargement
(>5 mm), the appearance of a new endoleak, evidence of perigraft flow, change in aneurysm
pulsatility, or migration resulting in an inadequate seal zone should prompt further investigation
and may indicate the need for additional intervention or surgical conversion.
•
Exercise care in the handling of the device and delivery technique to aid in the prevention of
vessel rupture.
•
Inappropriate patient selection may contribute to poor Endurant Stent Graft System performance.
Refer to Section 2 and Section 6 for specific information regarding patient selection.
•
The Endurant Stent Graft System should only be used by physicians and teams trained in
vascular interventional techniques, including training in the use of the Endurant Stent Graft
System. Refer to Section 9.1 for specific training expectations.
•
Do not use the Endurant Stent Graft in patients unable to undergo the necessary preoperative
and postoperative imaging and implantation studies. Refer to Section 9.9.
•
Always have a vascular surgery team available at institutions performing endovascular grafting
in the event that conversion to open surgical repair is required.

4.2. Patient Selection, Treatment, and Follow-up

•
Do not use the Endurant Stent Graft System in patients that have systemic infection, or are
suspected of having systemic infection.
•
Do not use the Endurant Stent Graft System in patients with sensitivities or allergies to the
Endurant Stent Graft System materials. These materials include (* Denotes materials that are a
part of the delivery system but do not contact the patient):
Polyether Block Amide (PEBA)
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Polyether Block Amide (PEBA) with Barium-Sulfate filler
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Polyamide 12
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Acrylonitrile-Butadiene-Styrene (ABS) copolymer*
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Stainless steel
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Platinum-Iridium alloy
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Nickel-Cobalt-Chromium-Molybdenum alloy
■
Nickel-Titanium (Nitinol) alloy
■
Ethylene Propylene Rubber*
■
Silicone
■
Polycarbonate
■
Photo-reactive polyvinylpyrrolidone copolymer
■
Platinum
■
Gold
■
Polyester
■
Polyethylene
■
•
The Endurant Stent Graft System does not contain natural rubber latex. However during the
manufacturing/assembly process, the Endurant Stent Graft System may have incidental contact
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Figure 7. Endurant Iliac Delivery System
5. Proximal Graft Cover Tubing
6. Taper tip
7. Distal Graft Cover Tubing
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