MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CORE VALVE EVOLUT PRO+; AORTIC VALVE, PROSTHESIS PERCUTANEOUSLY

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2019

Event Type  malfunction  

Event Description

A 29mm core valve evolut pro+ (b)(4) when deploying the device, the nitinol frame did not open.The device was reconstrained and attempted to deploy slightly deeper into lv but again the stent frame did not open.The device was reconstrained and removed from the body.Balloon valvuloplasty was performed with the hope that a second valve would deploy and open normally.A second evolut pro+ deployment was attempted but again the nitinol frame did not open.Therefore the valve was reconstrained and removed from the body.A 26 mm sapien 3 was implanted without difficulty.No pt harm issues.Fda safety report ids# (b)(4).

• Brand Name: CORE VALVE EVOLUT PRO+
• Type of Device: AORTIC VALVE, PROSTHESIS PERCUTANEOUSLY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION
• MDR Report Key: 9539974
• MDR Text Key: 173669353
• Report Number: MW5091989
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1