How Supplied; Clinician Use Information - Medtronic Endurant Manual Del Usuario

2011/DEC/22 at 7:46 p.m. Doc number: M716803B001 [multi23]
•
Risks and benefits related to endovascular repair.
•
Differences between endovascular repair and surgical repair.
•
Possibility that subsequent endovascular or open surgical repair of the aneurysm may be
required.
•
The long-term safety and effectiveness of endovascular repair has not been established.
•
Physicians should advise all patients that this treatment modality requires long-term, regular
follow-up to assess patients' health status and stent graft performance.
•
Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms) should be
monitored closely.
Medtronic Vascular recommends that the physician disclose to the patient (in written form) all risks
associated with treatment using the Endurant Stent Graft System. Details regarding risks occurring after
implantation of the device are contained in the Patient Information sheet. Please follow EVAR protocol
required from each treating institution.

8. How Supplied

The Endurant Stent Graft System Components are available in the sizes described in Table 2
through Table 6.
Table 2. Sizing Chart - Bifurcated Stent Graft Component
OD (Fr.) Proximal x Distal Diameter
(mm x mm)
20
18
Table 3. Sizing Chart – Aorto-Uni-Iliac Stent Graft Component
OD (Fr.) Proximal x Distal Diameter
(mm x mm)
20
18
Table 4. Sizing Chart – Aortic Extension & Abdominal Tube Components
OD (Fr.) Proximal x Distal Diameter
(mm x mm)
20
18
Table 5. Sizing Chart – Contralateral Limb Component
OD (Fr.) Proximal x Distal Diameter
(mm x mm)
16 16 x 28
16 x 24
16 x 20
14 16 x 16
16 x 13
16 x 10
Table 6. Sizing Chart – Iliac Extension Component
OD (Fr.) Proximal x Distal Diameter
(mm x mm)
18
16
14
8.1. Sterility
Each Endurant Stent Graft Component (bifurcated, contralateral limb, aortic extension, abdominal tube,
iliac extension, and AUI) is individually contained within an Endurant Delivery System. The Endurant
Delivery System is sterilized using electron beam radiation and is supplied sterile for single use only.
•
Do not reuse or attempt to resterilize.
•
Do not use if package is opened or damaged.
8.2. Contents
•
One (1) Endurant Stent Graft System
•
One (1) Instructions for Use
8.3. Storage
Store at room temperature in a dark, dry place.

9. Clinician Use Information

9.1. Physician Training Program
Caution: The Endurant Stent Graft System should only be used by physicians and teams trained in
vascular interventional techniques and in the use of this device.
The recommended skill/knowledge requirements for physicians using the Endurant Stent Graft System
are outlined below:
Patient Selection:
•
Knowledge of the natural history of abdominal aortic aneurysms (AAA) and co-morbidities
associated with AAA repair.
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Covered Length
(mm)
36 x 20 145, 170
36 x 16
32 x 20 120, 145, 170
32 x 16
28 x 20
28 x 16
28 x 13
25 x 16
25 x 13
23 x 16
23 x 13
Covered Length
(mm)
36 x 14 105
32 x 14
28 x 14
25 x 14
23 x 14
Covered Length
(mm)
36 x 36 45 / 70
32 x 32
28 x 28
25 x 25
23 x 23
Covered Length
(mm)
80, 95, 120
Covered Length
(mm)
28 x 28 80
24 x 24
20 x 20
13 x 13
10 x 10
Vessel Inner Dia. (mm)
29–32
26–28
23–25
21–22
19–20
Vessel Inner Dia. (mm)
29–32
26–28
23–25
21–22
19–20
Vessel Inner Dia. (mm)
29–32
26–28
23–25
21–22
19–20
Vessel Inner Dia. (mm)
23–25
19–22
15–18
12–14
10–11
8–9
Vessel Inner Dia. (mm)
23–25
19–22
15–18
10–11
8–9