Events

Recall of Device Recall Ovation Prime Abdominal Stent Graft System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Trivascular, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67672
  • Event Risk Class
    Class 2
  • Event Number
    Z-1297-2014
  • Event Initiated Date
    2014-02-27
  • Event Date Posted
    2014-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126008
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, endovascular graft, aortic aneurysm treatment - Product Code MIH
  • Reason
    Communication to european physician users of the ovation prime abdominal stent graft system to notify them of changes to instructions for use.
  • Action
    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.

Device

Device Recall Ovation Prime Abdominal Stent Graft System
  • Model / Serial
    All codes
  • Product Classification
    Cardiovascular Devices
  • 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
    Trivascular, Inc

Manufacturer

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