MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number	27MJ-501
Medical Device Problem Codes	Fracture (1260); Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 27mm sjm masters series mechanical heart valve was chosen for a procedure.After the valve suture was completed, intraoperative color doppler ultrasound revealed poor leaflet mobility.When the chest was reopened, it was found that there were leaflet fragments that had fallen off and were floating in the arterial vessels.The surgeon kept searching for them, which led to a delay of more than 10 hours in the operation time and also added many complex steps to the surgical procedure.A new 27mm sjm masters series mechanical heart valve was chosen and completed the procedure.The patient is currently in the intensive care unit.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6 )2026, a 27mm sjm masters series mechanical heart valve was chosen for a procedure.After the valve suture was completed, intraoperative color doppler ultrasound revealed poor leaflet mobility.When the chest was reopened, it was found that there were leaflet fragments that had fallen off and were floating in the arterial vessels.The surgeon kept searching for them, which led to a delay of more than 10 hours in the operation time and also added many complex steps to the surgical procedure.A new 27mm sjm masters series mechanical heart valve was chosen and completed the procedure.The patient is currently in the intensive care unit and reported recovering.
Additional Manufacturer Narrative
An event of valve leaflets misaligned when opening and closing and subsequent leaflet fracture was reported.A returned device analysis could not be performed as the device was not returned to abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The root cause of the leaflet fracture could not be conclusively determined.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.However, this cannot be determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES MECHANICAL HEART 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 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24717963
• Report Number: 2135147-2026-01974
• Device Sequence Number: 6121765
• Product Code: LWQ
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 06/25/2026

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: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: C00026779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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: Other; Required Intervention
• Patient Sex: Unknown