Note: This section should not be used in place of the Instructions for Use. This section only provides an overview of the procedure. Refer to the Instructions for Use for additional information.1
Access the vessel and perform an angiogram using standard technique to measure the diameter of the vessel at the desired occlusion site.
Select a vascular plug with a diameter approximately 30-50% larger than the vessel diameter at the occlusion site. Ensure that the occlusion site has sufficient length so the deployed device length will not obstruct other vessels or anatomical structures.
| Deployment Steps | |
|---|---|
| 1 | a) Flush with sterile saline through the stop cock until fluid exits the distal tip to purge air from the loader. NOTE: If the AVP 4 is inadvertently deployed before use, follow these additional steps prior to use: b) grasp the spring-loaded tapered loader tubing and the rotating luer in one hand and retract the delivery wire with the other hand. c) Continue to retract the delivery wire until both the single white marker and the double white markers on the delivery wire are visible. Make sure the device is fully retracted into the loader. d) Reflush the device if necessary. |
| 2 | Remove device (in loader) and delivery wire from the hoop dispenser. |
| 3 | Select a delivery catheter with an internal diameter that will accommodate the selected device. The original access catheter may be used if the internal diameter is sufficient for the selected device. Prepare the catheter for use (according to the manufacturer’s instructions for use). |
| 4 | Advance the delivery catheter over the guidewire until the distal tip of the catheter is at the distal edge of the occlusion site (according to the manufacturer’s instructions for use). |
| 5 | Remove the guidewire. |
| 6 | Insert the tapered tip of the loader into the hub of the 0.038 inch guidewire compatible diagnostic catheter. NOTE: Do not connect the luer through a stopcock, hemostasis valve, Y-connector or other valve. This will result in damage to the loader. |
| 7 | Grasp the rotating luer and press the luer to the hub of the catheter and rotate clockwise to ensure full engagement of the loader to the catheter hub. |
| 8 | Advance the delivery wire until the double white marker is as the hemostasis valve. |
| 9 | Hold delivery wire in place and slowly retract the delivery catheter to deploy the device at the occlusion site. |
| 10 | Verify position of the device using the radiopaque marker bands. ~ If unsatisfactory, stabilize the wire and re-advance the delivery catheter until the device is completely within the catheter. Reposition and deploy, or remove the device from the patient. ~ If satisfactory, attach the plastic vise to the wire and rotate the delivery wire counterclockwise until it separates from the device. |
| 11 | Remove delivery catheter and wire from the patient. |
MAT-2002814 v1.0
AMPLATZER™ Vascular Plug
Intended Use: The AMPLATZER™ Vascular Plug 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:
Handling
Through non-clinical testing, the AMPLATZER™ Vascular Plug has been shown to be MR safe at field strengths of 3.0 Tesla or less with a maximum whole body averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 Tesla and 5.57 W/kg at 5.0 Tesla for a 20 minute exposure to a B1 of 118 μT. The AMPLATZER™ Vascular Plug should not migrate in this MR environment. Non-clinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 Tesla.
In this testing, the device produced a temperature rise of 1.1°C at 1.5 Tesla and 1.6°C at 5.0 Tesla.
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.
Potential Adverse Events: Potential complications include, but are not limited to: death, embolization of the device, hematoma at the site of entry, stroke, or vessel perforation, or embolization of the device.
State of California (USA) Only: WARNING: This product and its packaging have been sterilized with ethylene oxide. The packaging may expose you to ethylene oxide, a chemical known to the State of California to cause cancer or birth defects or other reproductive harm.
AMPLATZER™ Vascular Plug II
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:
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:
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 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.
Potential Adverse Events: Potential complications include, but are not limited to: death, migration of the device, stroke, or vessel perforation.
AMPLATZER™ Vascular Plug 4
Indications And Usage: The AMPLATZER™ Vascular Plug 4 is indicated for arterial and venous embolizations in the peripheral vasculature.
Contraindications: None known.
Warnings:
Precautions:
Non-clinical testing has demonstrated that the AMPLATZER™ Vascular Plug 4 device is MR Conditional. It can be scanned safely under the following conditions:
MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the device. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this implant.
Potential Adverse Events: Potential adverse events that may occur during or after a procedure placing this device include, but are not limited to:
MAT-2103601 v1.0
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Precautions
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