AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Recall
- Recall Number
- Z-1039-2017
- Event Number
- 76113
- FEI Number
- 3011063223
- Product Code
- MIH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 27, 2016
- Posted
- January 19, 2017
- Terminated
- April 28, 2017
- Address
- Endologix 35, Hammond Irvine, CA, 92618-1607
Description
AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
Endologix sent a Dear Phycisicans Letter dated June 2, 2015, to all affected customers to inform them of the enclosed 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The letter informs the customers of the update reports the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System). On January 2016, a Dear Physician letter was sent to inform the customers of the 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. Customers were informed the update reports the cumulative clinical data and commercial experience (i.e., post-market surveillance) of the Powerlink System and the AFX Endovascular AAA system and contains important information and recommendations regarding the continued safe and effective use of these devices. On 12/27/16, a Dear Physician letter was sent to inform customers of the important information related to the AFX Endovascular AAA System (AFX System). The letter informs the customers of a series of updates to the Instructions for Use (IFU) and modifications to the product were implemented, including introduction of a graft material processing improvement known as Duraply. The letter informs the customers that at the time of the submission of these modifications to FDA, they were not identified as measures intended to address Type III endoleaks. The on-going Endologix investigation has determined that these changes may help prevent the occurrence of Type III endoleaks reported with the AFX device. Customers with any questions are instructed to contact their Endologix representative.
Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
4,143 devices