Intended Use; Contraindications; Warnings; Precautions - Amplatzer Vascular Plug II Instrucciones De Uso

Table 1. AMPLATZER
Order Numbers
For Vascular
Plug II Devices
9-AVP2-003
9-AVP2-004
9-AVP2-006
9-AVP2-008
9-AVP2-010
9-AVP2-012
9-AVP2-014
9-AVP2-016
9-AVP2-018
9-AVP2-020
9-AVP2-022
* Refer to delivery catheter or sheath manufacturer's product labeling for inner diameter (ID).

Intended Use

The AMPLATZER Vascular Plug II is indicated for arterial and venous embolizations in the
peripheral vasculature.

Contraindications

None known.

Warnings

The safety and effectiveness of this device for cardiac uses (for example, patent ductus
arteriosus or paravalvular leak closures) and neurological uses have not been established.

Precautions

• For single use only. Do not reuse or re-sterilize.
• Use before the expiration date noted on the product packaging.
• Patients with nickel allergy may experience an allergic reaction to this device.
• Store in a dry place.
• Do not use if the packaging sterile barrier is opened or damaged.
• MR Conditional
Through non-clinical testing, AMPLATZER devices have been shown to be MR Conditional. A
patient with an implanted AMPLATZER device can be scanned safely immediately after placement
of the device under the following conditions:
• Static magnetic field of 3 T or less
• Spatial gradient magnetic field of 720 G/cm or less
• Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of
3 W/kg for 15 minutes of scanning
During testing, the device produced a clinically non-significant temperature rise at a maximum
MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for
15 minutes of MR scanning in a 3-tesla MR system using a transmit/receive body coil.
MR image quality may be compromised if the area of interest is in the exact same area or
relatively close to the position of the device. Therefore, optimization of MR imaging
parameters to compensate for the presence of this device may be necessary.
® Vascular Plug II Sizes and Corresponding Delivery Catheter Dimensions
Dimensions of Vascular Plug II
(fully expanded)
Diameter Length
(mm) (mm)
3 6
4 6
6 6
8 7
10 7
12 9
14 10
16 12
18 14
20 16
22 18
Dimensions of Delivery Catheter or Sheath
Minimum Inner Maximum Inner
Diameter* (mm) Diameter* (mm)
1.4
1.4
1.4
1.4
1.8
1.8
2.2
2.2
2.5
2.5
2.5
2
Maximum
Length (cm)
1.7 100
2.5 100
2.5 100
2.7 100
2.7 100
2.7 100
2.7 100
2.7 100
2.7 100
2.7 100
2.7 100