MAUDE Adverse Event Report: MEDTRONIC FREESTYLE AORTIC ROOT HEART VALVE

Model Number B251965

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aortic Insufficiency (1715); Dyspnea (1816)

Event Date 03/02/2015

Event Type  Injury  

Event Description

Pt had aortic valve replacement and cabg x 1 on (b)(6) 2014.Readmitted on (b)(6) 2015 due to shortness of breath.Echo performed on same day showed severe, eccentric aortic insufficiency.On (b)(6) 2015, doctor performed a re-operation, replacing the prosthetic valve.He stated from visual inspection of the failed implant, he could not determine why it would not function properly.

• Brand Name: AORTIC ROOT HEART VALVE
• Type of Device: HEART VALVE
• Manufacturer (Section D): MEDTRONIC FREESTYLE; minneapolis MN 55432
• MDR Report Key: 4627970
• MDR Text Key: 5660137
• Report Number: MW5041586
• Device Sequence Number: 1
• Product Code: LWR
• 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: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B251965
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 71