MAUDE Adverse Event Report: Medtronic Heart Valves Division Mosaic Aortic Bioprosthetic Heart Valve; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	305U223
Medical Device Problem Codes	Calcified (1077); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Syncope/Fainting (4411); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 12 years post implant of this 23mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement.The reason for evaluation was reported as severe aortic central regurgitation/insufficiency, valve stenosis.It was reported that the patient also experienced a syncopal episode.No intervention or adverse patient effects were reported.
Event or Problem Description
Additional information received reported that an intervention was planned for (b)(6)2026.Evidence of calcification was seen in the the left ventricular outflow tract (lvot) under right coronary cusp (rcc), left coronary cusp (lcc), and non coronary cusp (ncc).No additional adverse patient effects were reported.
Event or Problem Description
Additional information received reported that on (b)(6) 2026 the patient had a 23mm aortic transcatheter valve-in-valve replacement.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.
Additional Manufacturer Narrative
B2m, b5 and h6 codes were 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
B2, b5 and imf (annex f) code were 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.

• Brand Name: Mosaic Aortic 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 ; +353(091)708096
• MDR Report Key: 50517390
• Report Number: 2025587-2026-00973
• Device Sequence Number: 21511917
• Product Code: DYE
• UDI-Device Identifier: 00643169001664
• UDI-Public: (01)00643169001664(17)190723
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2026

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: 07/23/2019
• Device Model Number: 305U223
• Device Catalogue Number: 305U223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Supplement Date Received by Manufacturer: Not provided; 09/03/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/02/2026; 09/15/2026
• Date Device Manufactured: 08/11/2014
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 88 LB