MAUDE Adverse Event Report: Medtronic Heart Valves Division Mosaic Aortic Bioprosthetic Heart Valve; REPLACEMENT HEART-VALVE

Model Number	305U229
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury

• Brand Name: Mosaic Aortic Bioprosthetic Heart Valve
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): Medtronic Heart Valves Division; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): Medtronic Heart Valves Division; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50762976
• Report Number: 2025587-2026-01038
• Device Sequence Number: 9668322
• Product Code: DYE
• UDI-Device Identifier: 00643169001480
• UDI-Public: (01)00643169001480(17)170319
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2017
• Device Model Number: 305U229
• Device Catalogue Number: 305U229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 05/02/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male