Indications And Usage; Contraindications - AGA Medical AMPLATZER Mode D'emploi

Table 1. AMPLATZER Duct Occluder II Sizing Chart. Determine the correct device order number based on the
measured diameter and length of the ductus.
< 2.5 mm
2.5 mm–3.5 mm
3.6 mm–4.5 mm
4.6 mm–5.5 mm
Table 2. AMPLATZER Duct Occluder II and delivery system sizes.
Device Order
Number
9-PDA2-03-04
9-PDA2-04-04
9-PDA2-05-04
9- PDA2-06-04
9- PDA2-03-06
9- PDA2-04-06
9- PDA2-05-06
9- PDA2-06-06

2. Indications and Usage

The AMPLATZER Duct Occluder II is a percutaneous transcatheter occlusion device intended for the non-surgical
closure of patent ductus arteriosus.

3. Contraindications

3.1 Patients weighing less than 6 kg.
3.2 Patients less than 6 months of age.
3.3 Patients more than 18 years of age.
3.4 Patients with a window-type patent ductus arteriosus.
3.5 Patients with a right-to-left shunt through the patent ductus arteriosus.
3.6 Patients with cardiac anomalies requiring surgical or interventional correction.
3.7 Patients who have had more than 2 lower respiratory infections within the last year.
3.8 Patients with an active infection.
3.9 Patients with contraindication to anticoagulation treatment.
Measured Ductus Length
< 5 mm 5 mm–8 mm
9-PDA2-03-04 9-PDA2-03-06
9-PDA2-04-04 9-PDA2-04-06
9-PDA2-05-04 9-PDA2-05-06
9-PDA2-06-04 9-PDA2-06-06
Waist Diameter
(fully expanded)
[mm (in)]
3 (0.12)
4 (0.16)
5 (0.20)
6 (0.24)
3 (0.12)
4 (0.16)
5 (0.20)
6 (0.24)
8.1 mm–10 mm
9-PDA2-04-06
9-PDA2-05-06
9-PDA2-05-06
9-PDA2-06-06
Disc Diameter
(fully expanded)
[mm (in)]
9 (0.35)
10 (0.39)
11 (0.43)
12 (0.47)
9 (0.35)
10 (0.39)
11 (0.43)
12 (0.47)
2
10.1 mm–11 mm
9-PDA2-05-06
9-PDA2-06-06
9-PDA2-06-06
9-PDA2-06-06
Nominal Recommended
Length TorqVue
[mm (in)] Delivery System
4 (0.17) 4 Fr
4 (0.17) 4 Fr
4 (0.17) 5 Fr
4 (0.17) 5 Fr
6 (0.25) 4 Fr
6 (0.25) 4 Fr
6 (0.25) 5 Fr
6 (0.25) 5 Fr
11.1 mm–12 mm
9-PDA2-06-06
9-PDA2-06-06
9-PDA2-06-06
9-PDA2-06-06
® LP