Device Recall Ovation Prime Abdominal Stent Graft System

  • Model / Serial
    All codes
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution including Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Norway, Poland, Spain, and Sweden.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Trivascular, Inc, 3910 Brickway Blvd, Santa Rosa CA 95403
  • Manufacturer Parent Company (2017)
  • Source
    USFDA