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

Model Number	500FA23
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during the implant of this 23mm open pivot mechanical valve, it was explanted and replaced with an unknown product.The reason for the replacement was reported due to a valve size mismatch. during the procedure, after the surgeon used the valve sizing tool to measure the annulus size at both ends, a 23mm valve was opened for implantation.However, it was found that the valve was slightly undersized and could not be smoothly placed into the annulus. continued use carried a risk of patient-prosthesis mismatch (ppm), so it was removed. 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.

• Brand Name: AORTIC FLEX
• 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)708096
• MDR Report Key: 50456486
• Report Number: 3008592544-2026-00059
• Device Sequence Number: 13220962
• Product Code: LWQ
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 08/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 500FA23
• Device Catalogue Number: 500FA23
• 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: 08/21/2026
• Initial Report FDA Received Date: 08/26/2026
• Date Device Manufactured: 06/26/2025
• 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
• Patient Sex: Unknown