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

Model Number	310MN33
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information received reported that the 33mm mosaic neo bioprosthetic valve malfunctioned.It was reported that the mosaic neo bioprosthetic valve was fully sutured and tested prior to removal.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that during the implant of this 33mm mosaic neo bioprosthetic valve, it was explanted and replaced with a non-medtronic product.The reason for the replacement was reported as poor coaptation of the valve leaflets.It was further reported that abnormal leaflet movement was noted when checking the valve after implantation using an asepto syringe and red rubber catheter. it was noted that the case required longer clamp and bypass time to complete.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
B5 and d9 updated.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: Mosaic NEO 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: 50522106
• Report Number: 2025587-2026-00974
• Device Sequence Number: 13439278
• Product Code: DYE
• UDI-Device Identifier: 00763000990596
• UDI-Public: (01)00763000990596(17)310414(20)01
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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 Model Number: 310MN33
• Device Catalogue Number: 310MN33
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Supplement Date Received by Manufacturer: 09/19/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 04/15/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 146 LB