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Amplatzer™ Valvular Plug III
en: Instructions for Use
Device Description
The Amplatzer™ Valvular Plug III is a self-expandable nitinol mesh occlusion device. The
device has a radiopaque marker band at each end and a screw attachment at one end for
attaching to the delivery wire. A radiopaque platinum marker is sewn to the nitinol mesh of
the device, centered in the long axis at the edge of the distal lobe, to indicate the orientation
of the device in the paravalvular space.
The device is shipped attached to a delivery wire in a hoop dispenser. A plastic vise is also
included and may be attached to the delivery wire to facilitate device detachment.
Refer to the figures and tables in Appendix A: Supplemental Information for more information
about the device. Device dimensions are provided in Table 1, and sizing information is
provided in Table 2. The following device components are identified in Figure 1 and Figure 2:
Figure 1
E. Marker bands
F.
Nitinol mesh
G. Screw attachment
H. Platinum marker
Indications and Usage
The Amplatzer™ Valvular Plug III (AVPIII) is intended for percutaneous, transcatheter
closure of a paravalvular leak that has developed after an aortic or mitral mechanical surgical
valve implant procedure. The device is indicated for patients with a clinically significant
paravalvular leak showing signs of heart failure and/or paravalvular leak-associated
hemolysis, necessitating recurring blood transfusions.
Contraindications
The Amplatzer™ Valvular Plug III is contraindicated for:
• Patients in active sepsis (including endocarditis) with positive blood cultures at the time
of procedure;
• Patients with rocking valve;
• Placement near a bioprosthetic valve;
• Patients with extensive paravalvular leak (greater than half of the valve perimeter);
• Patients with intracardiac mass, vegetation, tumor, or thrombus at any site utilized for
paravalvular leak access, or documented evidence of venous thrombus in the vessels
through which access to the paravalvular leak is gained;
• Patients whose vasculature, through which access to the paravalvular leak is gained, is
inadequate to accommodate the appropriate sheath size;
• Patients with the anatomy in which the required Amplatzer™ Valvular Plug III device
size would interfere with other intracardiac or intravascular structures, such as valves
(other than the treated valve), pulmonary veins, or coronary ostia;
• Patients in which the minor axis of the paravalvular leak exceeds the minor axis of the
largest Amplatzer™ Valvular Plug III device (i.e., width of the paravalvular leak exceeds
the width of the largest available Amplatzer™ Valvular Plug III device);
• Patients with paravalvular leaks from a transcatheter aortic or mitral valve replacement
(TAVR or TMVR) or paravalvular leaks from surgical repair of the valve (such as
annuloplasty with rings);
• Pediatric patients;
• Patients in cardiogenic shock or in acute decompensation of heart failure; or
• Patients with myelodysplasia.
Figure 2
I.
Hoop dispenser
J.
Delivery wire
K. Loader
L.
Device
M. Plastic vise
1
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