MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION COREVALVE EVOLUT R SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number EVOLUTR-34-US

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6) registry: the information was received in a de-identified format from a third-party post-implant device registry, the (b)(6) registry.Under the terms and conditions of the registry, anonymized patient demographics details and limited details were provided regarding the adverse events and outcomes, including time-to-event references in the number of days from the initial device implant procedure for reported observations.The reported event information did not include any device-specific identifying information, location where the events occurred or the specific dates of device implant procedures or events subsequently associated with the device or procedure.Without such information, it cannot be determined if any of these events were previously reported to medtronic or the fda maude database, or if any devices were returned to medtronic for analysis.The event date reported here and the date of this report is the date the information was received by medtronic.Because the device serial number is not reported, a review of device history records could not be performed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding patient/device events via a third-party post-implant device registry (the (b)(6) registry).Medtronic received information that during the implant of this transcatheter bioprosthetic valve an aortic valve re-intervention occurred due to a device fracture.A second valve was successfully implanted valve in valve.No other adverse patient effects were reported.

• Brand Name: COREVALVE EVOLUT R SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7281977
• MDR Text Key: 100418600
• Report Number: 2025587-2018-00415
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVOLUTR-34-US
• Device Catalogue Number: EVOLUTR-34-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 100