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

Lot Number 13857137

Device Problem Insufficient Information (3190)

Patient Problem Aortic Valve Stenosis (1717)

Event Type  Injury  

Event Description

Medtronic received information that five years post implant of this bioprosthetic valve, transthoracic echocardiogram (tte) revealed increased av gradient.Ct angiogram showed thickening and mild calcification of the valve.On (b)(6) 2018 a transcatheter aortic valve was placed inside the existing st.Jude 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: 17531095
• MDR Text Key: 321134249
• Report Number: MW5138011
• 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: 06/01/2018

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 Lot Number: 13857137
• Patient Sequence Number: 1