Class 2 Device Recall COREVALVE EVOLUT R SYSTEM

• Date Initiated by Firm: August 03, 2016
• Date Posted: August 16, 2016
• Recall Status: Terminated on March 31, 2017
• Recall Number: Z-2546-2016
• Recall Event ID: 74796
• PMA Number: P130021S014
• Product Classification: Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
• Product: 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.
• Code Information: all lots
• Recalling Firm/ Manufacturer: Medtronic Cardiovascular Surgery-the Heart Valve Division; 1851 E Deere Ave; Santa Ana CA 92705-5720
• Manufacturer Reason for Recall: Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
• FDA Determined Cause: Device Design
• 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).
• Quantity in Commerce: 7,319 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NPT and Original Applicant = Medtronic, Inc.