Events

Recall of 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
    69326
  • Event Risk Class
    Class 1
  • Event Number
    Z-0125-2015
  • Event Initiated Date
    2014-09-20
  • Event Date Posted
    2014-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130243
  • 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
    Trivascular has identified select lots of ovation prime 29mm aortic body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the autoinjector during the fill polymer injection step of the primary implant procedure.
  • Action
    Urgent Field Safety Notice letter was sent to all consignees on 9/19/14 via trackable mail system. Users are notified that TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to the Autoinjector during the fill polymer injection step of the primary implant procedure.

Device

Ovation Prime Abdominal Stent Graft System
  • Model / Serial
    The devices subject to this action are labeled for distribution outside of the United States; therefore, no UDI is on the device label or package.  Model Number: TV-AB2980-D  Lot Numbers: FS031814-11 FS052214-22 FS052814-36 FS040414-21 FS050614-56 FS040714-53 FS040514-02 FS042614-05 FS050614-53 FS032614-46 FS050214-27 FS050314-12 FS052214-48 FS052214-53 FS031814-44 FS031814-49 FS032714-04 FS032714-20 FS040414-30 FS040514-08 FS050114-01 FS050114-08 FS050514-18 FS050514-27 FS050614-54 FS050614-55 FS051914-32 FS051914-34  Expiry dates ranging "May-17" through "Jun-17"
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    International Distribution Only -- Canada, Turkey, Austria, Ireland, Belgium, Italy, Switzerland, Spain, France, and Cyprus.
  • Product Description
    Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. || The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).
  • 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