MAUDE Adverse Event Report: MEDTRONIC 29MM EVOLUT COREVALVE; AORTIC VALVE, PROSTHESIS

Device Problems Break (1069); Detachment Of Device Component (1104); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2017

Event Type  Injury  

Event Description

A 29 mm corevalve evolut handle broke while trying to recapture the device and reposition it.Specifically, the blue handle which unsheathe the valve broke into two pieces and fell apart while the valve was partially deployed in the lvot.The device was successfully deployed without complications to the patient, but this is potentially a life threatening device failure.

• Brand Name: 29MM EVOLUT COREVALVE
• Type of Device: AORTIC VALVE, PROSTHESIS
• Manufacturer (Section D): MEDTRONIC; minneapolis MN
• MDR Report Key: 6485622
• MDR Text Key: 72727451
• Report Number: MW5069036
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• 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 Outcome(s): Life Threatening
• Patient Age: 85 YR
• Patient Weight: 55