Indications And Usage; Contraindications - Amplatzer Duct Occluder II Instrucciones De Uso

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