MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC; REPLACEMENT HEART-VALVE

Model Number	305U29
Medical Device Problem Codes	Calcified (1077); Material Split, Cut or Torn (4008); Thickening of Material (4056); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Foreign Body Reaction (1868); Cusp Tear (2656); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
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
It was reported that a 29mm aortic tissue valve was explanted and a 29mm aortic tissue valve of a different model was implanted in the aortic position during a procedure on (b)(6) 2025.The reason for the replacement was reported as severe aortic regurgitation and aortic stenosis.The patient also had symptoms of dyspnea on exertion.A maze procedure was also performed concomitantly.During the explant, it was found that the valve had heavily calcified leaflets with holes and dense pannus.No patient complications have beenreported as a result of this event.

• 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 ; 091708096
• MDR Report Key: 21998753
• Report Number: 2025587-2025-03590
• Device Sequence Number: 8814842
• Product Code: DYE
• UDI-Device Identifier: 00885074253275
• UDI-Public: 00885074253275
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2025
• 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): 05/09/2025

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: 305U29
• Device Catalogue Number: 305U29
• 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: 04/17/2025
• Initial Report FDA Received Date: 05/09/2025
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 107 KG