MAUDE Adverse Event Report: Medtronic, Inc. OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL

Model Number	505DM28
Medical Device Problem Codes	Incomplete Coaptation (2507); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a mitral valve replacement procedure, an ap360 mechanical heart valve was used.Prior to implantation, leaflet mobility was intact and leaflet closure was normal.After valve placement, saline testing showed that the leaflets could not fully close and significant regurgitation was observed.Adjustment of the leaflet angle was performed; however, repeat saline testing showed persistent incomplete leaflet closure without improvement.It was reported that the ap360 mechanical heart valve was explanted and replaced with a new mechanical valve.No patient complications have been reported as a result of this event.
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: OPEN PIVOT AP360 HEART VALVE
• 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 CA 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50476434
• Report Number: 2025587-2026-00964
• Device Sequence Number: 10112418
• Product Code: LWQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 09/10/2026

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 Model Number: 505DM28
• Device Catalogue Number: 505DM28
• 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: 08/26/2026
• Supplement Date Received by Manufacturer: Not provided; 09/07/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/03/2026; 09/10/2026
• Date Device Manufactured: 06/01/2025
• 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
• Patient Sex: Unknown