MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM MASTERS SERIES MECHANICAL HEART VALVE

Model Number 25MECJ-502

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Embolism (1829); Mitral Regurgitation (1964)

Event Date 12/22/2016

Event Type  Injury  

Event Description

Mitral valve replacement done in (b)(6) 2015.Pt now with mitral regurgitation.Mitral valve leaflet embolization to distal abdominal aorta.Mitral valve replacement re-do required.Future removal of leaflet from the aorta.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Manufacturer (Section D): ST. JUDE MEDICAL; st. paul MN 55117
• MDR Report Key: 6228266
• MDR Text Key: 64149058
• Report Number: MW5067068
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734008347
• UDI-Public: (01)05414734008347
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: 25MECJ-502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR