AtriCure IFU-0454.A LAA Exclusion System User Manual
- June 16, 2024
- AtriCure
Table of Contents
AtriCure IFU-0454.A LAA Exclusion System
CAUTION: Federal law (US) restricts this device to sale by or on the order of a physician.
IMPLANT CARD LEAFLET
INSTRUCTIONS FOR COMPLETION:
The following information should be completed by the healthcare institution/provider on the front of the implant card. ( See FIGURE 1 ).
- FIGURE 1
| Patient Identification
---|---
| Procedure Date
| Name and Address of the Implanting Healthcare Institution/Provider
Once the implant card is populated with information above, give both implant card leaflet and implant card to patient.
PATIENT INFORMATION:
The implant card serves as a record of the LAA Exclusion System implant you have received. The information on the implant card helps communicate information about this implant. It can be presented to physicians or airport security. The implant card should be presented anytime you are subject to a Magnetic Resonance Imaging (MRI) screening, as the information helps ensure the MRI does not interfere with the implanted device.
In the event you need to get a replacement card for your implant, you will need to have the UDI and lot information for your device off the rear of the card ( See FIGURE 2 ). Contact the manufacturer to request a replacement card.
In the unlikely event of any issues with the implant, the information on the implant card will ensure that your physician can inform you if you are impacted.
Device lifetime is equal to patient lifetime.
MR CONDITIONAL
Non-clinical testing demonstrated that the LAA Exclusion System Clip is MR Conditional. A patient with this device can be scanned safely in an MR system immediately after placement under the following conditions:
- Static magnetic field of 1.5-Tesla and 3-Tesla, only.
- Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m)(extrapolated) or less.
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the First Level Controlled Operating Mode of operation for the MR system.
- The scan conditions defined for the LAA Exclusion System Clip are expected to produce a maximum temperature rise of 2.9°C (5.22°F) for Gillinov-Cosgrove Clip (LAA, ACH1, ACH2, PRO1, PRO2 devices) and 3.1°C (5.58°F) for V Clip (FLEX·V, PRO·V devices) after 15-minutes of continuous scanning (i.e., per pulse sequence).
DEVICE CONTAINS
CGG CLIP| V CLIP
Titanium Grade 2| Titanium Grade 5
Polyurethane| Polyethylene Terephthalate
Nitinol| Titanium Dioxide
Polyethylene Terephthalate|
Titanium Dioxide
SYMBOLS GLOSSARY
| Medical Device| | Unique Device Identifier
| Batch Code| | MR Conditional
| Manufacturer| | Healthcare center or doctor
| Procedure Date| | Patient
Identification
| Patient Information Website
| Caution: Federal (US) law restricts this device to sale by or on the
order of a physician or other licensed practitioner.
Customer Support
AtriCure Inc.
7555 Innovation Way
Mason, Ohio 45040 USA
+1 866 349 2342
+1 513 755 4100
