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

Device Problem Difficult to Open or Close (2921)

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

Event Date 12/13/2019

Event Type  malfunction  

Event Description

A 34mm core valve evolut pro+ serial # (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.There appeared to be "infolding" of the valve.A second evolut pro+ was deployed without problem.Fda safety report id# (b)(4).

• Brand Name: CORE VALVE EVOLUT PRO+
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION
• MDR Report Key: 9540039
• MDR Text Key: 173512838
• Report Number: MW5091991
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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
• Patient Age: 82 YR