MAUDE Adverse Event Report: Medtronic Heart Valves Division MOSAIC; REPLACEMENT HEART-VALVE

Model Number	305C25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction

• Brand Name: MOSAIC
• 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)7
• MDR Report Key: 50080911
• Report Number: 2025587-2026-00841
• Device Sequence Number: 20604435
• Product Code: DYE
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 305C25
• Device Catalogue Number: 305C25
• 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: 07/28/2026
• Initial Report FDA Received Date: 07/30/2026
• 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
• Patient Sex: Male