Events

Recall of COREVALVE EVOLUT R SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Cardiovascular Surgery-the Heart Valve Division.

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
    74796
  • Event Risk Class
    Class 2
  • Event Number
    Z-2546-2016
  • Event Initiated Date
    2016-08-03
  • Event Date Posted
    2016-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148472
  • 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
    Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
  • Reason
    Potential for vascular trauma with the use of the medtronic enveo r delivery catheter system (dcs).
  • Action
    Firm initiated a recall on 8/3/16 by sending an Urgent Medical Device Correction letter to inform them of the potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). The letter informs the customers of the recommendations to reduce the rate of vascular trauma events and the procedural uses. The letter informs the customers that the Evolut R System Instructions for Use (IFU) will also be updated appropriately consistent with the Dear Doctor communication. Patients with questions can contact Medtronic Cardiovascular Patient Services at 877-526-7890 (Monday-Friday, 7:30am-5pm Central Time). Customers with any questions are instructed to contact their Medtronic Field Representative or Lifeline Technical Services at 1-877-526-7890. On 8/19/16, firm sent a copy of a customer notification letter that will be sent to their customers to inform them that of the communication letter that was released in August 2016 by Medtronic regarding potential for aortic vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). The letter informs the customers that FDA classify the recall as a Class II recall and the recall does not require customers to return the product. The recall letter informs the customers that Medtronic has taken further action by updating all customer training materials and the Instructions for Use (IFU).

Device

COREVALVE EVOLUT R SYSTEM
  • Model / Serial
    all lots
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Morocco, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Product Description
    Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. || Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
  • Manufacturer
    Medtronic Cardiovascular Surgery-the Heart Valve Division

Manufacturer

Medtronic Cardiovascular Surgery-the Heart Valve Division
  • Manufacturer Address
    Medtronic Cardiovascular Surgery-the Heart Valve Division, 1851 E Deere Ave, Santa Ana CA 92705-5720
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA