MAUDE Adverse Event Report: Abbott Medical Masters Series Hemodynamic Plus Valve; Heart-Valve, Mechanical

Model Number	25AHPJ-505
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm sjm masters series hemodynamic plus valve was chosen for a procedure.During procedure, an inability of the valve to open was noted after weaning from cardiopulmonary bypass, during intraoperative transesophageal echocardiogram (tee) assessment.The patient was placed back on cardiopulmonary bypass for explanation of the valve and implantation of the biological valve.The patient need for repeat cardiopulmonary bypass and valve replacement resulted in prolonged cardiopulmonary bypass and myocardial ischemic times.The patient was reported stable.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

• Brand Name: Masters Series Hemodynamic Plus Valve
• Common Device Name: Heart-Valve, Mechanical
• Manufacturer (Section D): Abbott Medical; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): Abbott Medical Reg# 2648612; lot 20 b st caguas; caguas 00725 ; PR 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50845798
• Report Number: 2135147-2026-06378
• Device Sequence Number: 10060159
• Product Code: LWQ
• UDI-Device Identifier: 05415067043634
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P810002
• 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): 09/21/2026

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: 25AHPJ-505
• Device Catalogue Number: 25AHPJ-505
• Device Lot Number: C00038720
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2026
• 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: Disability; Required Intervention
• Patient Sex: Unknown