En: Instructions For Use; Device Description; Contraindications - Amplatzer Duct Occluder II Gebrauchsanweisung

AMPLATZER Duct Occluder II Additional Sizes
®

en: Instructions for Use

Device Description

The AMPLATZER Duct Occluder II Additional Sizes is a self-expanding, nitinol mesh
occlusion device for use in a patent ductus arteriosus (PDA). The central waist is designed to
fill the ductus. The retention discs are deployed in the pulmonary and aortic ends of the
ductus.
Radiopaque marker bands at each end of the occluder permit visibility during fluoroscopy.
Refer to the figures and tables on the foldout of the back cover for more information about
this device. Table T1 shows the dimensions of the occluder. Table T2 is the occluder sizing
table. Figures F1 and F2 identify the components.
Table T1
A. Retention disc diameter
B. Waist diameter
C. Length between retention discs
Table T2 and Figure F3
D. Ductus diameter
E. Ductus length
Indications and Usage
The AMPLATZER Duct Occluder II Additional Sizes is a percutaneous, transcatheter
occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).

Contraindications

The AMPLATZER Duct Occluder II Additional Sizes is contraindicated for patients
• who weigh less than 6 kg.
• younger than 6 months of age.
• with a window-type patent ductus arteriosus (length of less than 3 mm).
• with a right-to-left shunt through the ductus.
• with an aortic ampulla diameter smaller than the diameter of the ductus at the
pulmonary artery.
• with cardiac anomalies that require surgery or intervention.
• who have had more than 2 lower respiratory infections within the last year.
• with an active infection.
• with contraindications to anticoagulation treatment.
• with thrombus at the implant site.
• whose vasculature is not sufficient to reach the ductus with the specified catheter.
• with pulmonary hypertension with pulmonary vascular resistance of greater than 8
Wood units or an Rp/Rs of greater than 0.4.
• with a ductus longer than 8 mm (measured by angiography).
• with a ductus greater than 4 mm in diameter (measured by angiography).
Warnings
• Do not use the device if the sterile package is open or damaged.
• Use on or before the last day of the expiration month that is printed on the product
packaging label.
• This device was sterilized with ethylene oxide and is for single-use only. Do not reuse or
resterilize this device. Attempts to resterilize this device can cause a malfunction,
insufficient sterilization, or harm to the patient.
• Patients who are allergic to nickel can have an allergic reaction to this device.
Figure F1
F. Hoop dispenser
G. Vise
H. Delivery wire
J. Occluder
K. Occluder protector tube
Figure F2
L. Micro screw attachment
M. Radiopaque marker bands
1