MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC MITRAL BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	310C31
Medical Device Problem Codes	Calcified (1077); Material Split, Cut or Torn (4008); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Cusp Tear (2656); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 6 years and 2 months post implant of this 31mm mitral bioprosthetic valve, it was explanted and replaced with an unknown valve product.The reason for the replacement was reported as calcification and damaged leaflets, as 2 leaflets had holes in them.No additional adverse patient effects were reported.
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.
Event or Problem Description
Additional information was received that the valve was replaced with a non - medtronic valve.It was reported that moderate to severe regurgitation was noted prior to explant.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
B5 and h6 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
Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed a remnant of a green multifilament suture remains attached to the sewing ring.All leaflets were in the closed position.All leaflets were tan and showed signs of limited mobility which appeared to be associated with visible calcification.Calcification was observed on all leaflets.Off-white pannus was observed along the outflow margin of attachment of the right cusp.Leaflet deterioration was noted in the belly of the right and left cusps.The outflow and inflow surfaces of the non-coronary cusp appeared deteriorated.The left non-coronary and right non-coronary commissures appeared intact with some host tissue growth and calcification in the left right commissure.Thick, glistening off-white pannus adhered to the inflow and outflow of the sewing ring encroaching onto the rc and nc outflow railing.An unknown amount of pannus may have been removed during explant removal.The sewing ring appeared tattered, with small holes indicating the location of implantation sutures.Remnants of pannus were present along the sewing ring.Radiographic images revealed calcification on all leaflets of the valve.D9: updated h3: device evaluated? updated h6: updated the codes 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 MITRAL BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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 ; 091708096
• MDR Report Key: 23639583
• Report Number: 2025587-2025-05953
• Device Sequence Number: 9444181
• Product Code: DYE
• UDI-Device Identifier: 00643169001596
• UDI-Public: (01)00643169001596(17)240715
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 03/09/2026

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: 07/15/2024
• Device Model Number: 310C31
• Device Catalogue Number: 310C31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 02/19/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/03/2025; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2019
• 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; Life Threatening
• Patient Sex: Male