MAUDE Adverse Event Report: Medtronic, Inc. AORTIC VALVE GRAFT; HEART-VALVE, MECHANICAL

Model Number	502AG25
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury

• Brand Name: AORTIC VALVE GRAFT
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): Medtronic, Inc.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): Medtronic, Inc.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)7
• MDR Report Key: 50058330
• Report Number: 3008592544-2026-00054
• Device Sequence Number: 12772461
• Product Code: LWQ
• UDI-Device Identifier: 00763000429645
• UDI-Public: (01)00763000429645(17)261008
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/28/2026

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: 502AG25
• Device Catalogue Number: 502AG25
• 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: 07/21/2026
• Initial Report FDA Received Date: 07/28/2026
• Date Device Manufactured: 10/08/2021
• 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
• Patient Sex: Male