U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Communication to european physician users of the ovation prime abdominal stent graft system to notify them of changes to instructions for use.
조치
Trivascular sent an Important Medical Device Information letter dated February 27, 2014, to all European physicians who have scheduled cases through March 31, 2014 or until IFU;s are translated and available for European physicians. The letter provided notification of an update that will appear in a future revision of the product Instructions for Use (IFU). The IFU will be available in their country when the required translations and product registration/notification have been completed. This IFU does not require rework or return of the affected product. Customers with questions were instructed to contact their local TriVascular representative.
For questions regarding this recall call 707-543-8805.
Worldwide Distribution including Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Norway, Poland, Spain, and Sweden.
제품 설명
Ovation Prime Abdominal Stent Graft System; || Manufacturer: || TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 || The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.