MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC SURGICAL VALVE, 23MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Defective Component (2292)

Patient Problem Failure of Implant (1924)

Event Date 05/25/2023

Event Type  malfunction  

Event Description

A valve in valve procedure was performed, implanting a 23mm sapien 3 ultra resilia valve within a failed 23mm mosaic surgical valve, serial number (b)(6).Ew reference number: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MOSAIC SURGICAL VALVE, 23MM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION
• MDR Report Key: 17488060
• MDR Text Key: 320691420
• Report Number: MW5120784
• Device Sequence Number: 1
• Product Code: LWR
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1