Amplatzer Amulet Gebrauchsanweisung Seite 8

100105566_Amulet.book Page 1 Tuesday, May 20, 2014 1:05 PM
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AMPLATZER Amulet
en: Instructions for Use
Device Description
The AMPLATZER™ Amulet™ Left Atrial Appendage Occluder is a transcatheter, self-expanding
device intended for use in preventing thrombus embolization from the left atrial appendage. The
device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central
waist. Polyester patches are sewn into both the lobe and disc to facilitate occlusion. The lobe has
stabilizing wires to improve device placement and retention. The device has threaded screw
attachments at each end for connection to the delivery and loading cables. The device has
radiopaque markers at each end and at the stabilizing wires that permit visibility during
fluoroscopy.
Refer to the figures and tables on the foldout of the back cover for more information about the
device. Device and delivery sheath dimensions are provided in table T1, and sizing information is
provided in table T2. The following device components are identified in the figures:
F1
D. Proximal end screw
E. Waist of device
F. Lobe
G. Distal end screw
H. Marker bands
I. Stabilizing wires
J. Platinum thread
K. Disc
Indications and Usage
The AMPLATZER™ Amulet™ Left Atrial Appendage Occluder is a percutaneous transcatheter
device intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients
who have nonvalvular atrial fibrillation.
Contraindications
The AMPLATZER™ Amulet™ Left Atrial Appendage Occluder is contraindicated for patients:
• With the presence of intracardiac thrombus.
• With active endocarditis or other infections producing bacteremia.
• Where placement of the device would interfere with any intracardiac or intravascular
structures.
Warnings
• If the device is retracted while it is in the sheath, the device and the sheath must both be
removed and replaced. Failure to replace both the device and the sheath may result in
sheath and/or device malfunction.
• If the device is retracted farther than the radiopaque markers (fully recaptured), the device
and the sheath must both be removed and replaced. Failure to replace both the device and
the sheath may result in sheath and/or device malfunction.
• Physicians must be prepared to deal with urgent situations such as pericardial effusion or
device embolization that can require removal of the device. This includes availability of an
on-site surgeon.
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Left Atrial Appendage Occluder
F2
L. Loader with device
M. Loader hub
N. 14 Fr flush adaptor (for
sizes 28 mm–34 mm)
O. Hemostasis valve
P. Delivery cable
Q. Delivery cable vise
R. 14 Fr sheath adaptor (for
sizes 16 mm–25 mm)
S. Loading cable vise
T. Loading cable
1