MAUDE Adverse Event Report: EDWARDS LIFE SCIENCES THERMOFIX VALVE AORTI 23MM PERICARDIAL, PERIMONT MAGNA EASE; AORTIC VALVE PROSTHESIS

Model Number MAGNA EASE W/THERMAFI

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/12/2016

Event Type  Injury  

Event Description

Pt readmitted to (b)(6) center for re-do sternotomy; redo aortic root replacement due to dysfunction of prosthetic valve.

• Brand Name: THERMOFIX VALVE AORTI 23MM PERICARDIAL, PERIMONT MAGNA EASE
• Type of Device: AORTIC VALVE PROSTHESIS
• Manufacturer (Section D): EDWARDS LIFE SCIENCES
• MDR Report Key: 5409615
• MDR Text Key: 37537600
• Report Number: MW5059989
• Device Sequence Number: 1
• Product Code: NPT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/01/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: MAGNA EASE W/THERMAFI
• Device Catalogue Number: 3300TFX23
• Other Device ID Number: TEMP16495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 73