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

Model Number	310C27
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that during the implant of this 27mm mitral bioprosthetic valve, it was explanted and replaced with a new 27mm mitra l bioprosthetic valve of the same model or vice versa.The reason for the replacement was not reported.It was further reported that on the same day the patient was reported deceased.It was noted that the mitral device which remained implanted in the patient was unconfirmed.The cause of death was not received.Therefore, relatedness of the death to the valves could not be excluded.It is unknown whether an autopsy was performed.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: Mosaic Mitral 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: 50866012
• Report Number: 2025587-2026-01080
• Device Sequence Number: 10715549
• Product Code: DYE
• UDI-Device Identifier: 00643169594845
• UDI-Public: (01)00643169594845(17)300209
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 09/23/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 310C27
• Device Catalogue Number: 310C27
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 02/10/2025
• 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; Required Intervention; Death
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 170 LB