MAUDE Adverse Event Report: ST. JUDE SIZER, HEART-VALVE, PROSTHESIS

Model Number TF-23A

Device Problem Insufficient Information (3190)

Patient Problem Aortic Valve Stenosis (1717)

Event Type  Injury  

Event Description

Medtronic received information that 4 years and 7 months following implantation of the bioprosthetic valve, it was noted the patient had an elevation of the aortic valve mean gradient.A computed tomography angiography was performed on (b)(6) 2018 and a valve-in-valve procedure is scheduled for (b)(6) 2018.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SIZER, HEART-VALVE, PROSTHESIS
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17532371
• MDR Text Key: 321110208
• Report Number: MW5139279
• Device Sequence Number: 1
• Product Code: DTI
• 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: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: TF-23A
• Device Lot Number: 13880489
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1