MAUDE Adverse Event Report: ST. JUDE TRIFECTA; HEART-VALVE, MECHANICAL

Model Number 25MM TRIFECTA

Device Problem Insufficient Information (3190)

Patient Problem Endocarditis (1834)

Event Type  Injury  

Event Description

Medtronic received information that one year two months post implant of this aortic bioprosthetic valve, the patient was diagnosed with aortic valve endocarditis.Patient was treated with iv antibiotics.One year and four months after the valve implant, the valve was explanted and replaced with a 23mm st.Jude magna aortic valve.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TRIFECTA
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17528161
• MDR Text Key: 321090673
• Report Number: MW5135092
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 25MM TRIFECTA
• Patient Sequence Number: 1