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

Model Number	33MECJ-502
Medical Device Problem Codes	Incomplete Coaptation (2507); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)
Date of Event	01/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 10 jan 2026, a 33mm sjm masters series valve expanded cuff was implanted in the patient.Twenty four hours later, it was noted that the a thrombus was built on the valve.
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 33mm sjm masters series valve expanded cuff was implanted in the patient.Twenty four hours later, patient needed more inotropes and a transesophageal echocardiogram (tee) showed a thrombus was built on the valve.Intraoperatively, the patient was hemodynamically stable and dry, with no visible bleeding.However, in the intensive care unit, due to increased chest tube drainage output, medications were administered.The patient was reoperated the next day because one leaflet was not moving.The patient was reported recovered.
Additional Manufacturer Narrative
An event of leaflet incomplete coaptation, (valve explanted due to leaflets not moving normally) and thrombus on the valve was reported.The valve was returned with tissue present.Both leaflets were noted to be immobile due to the excessive tissue.Sutures were present on the cuff.No other anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of reported problem thrombus could not be conclusively determined.The material on the valve may have contributed to the limited mobility of one of the leaflets.However, this could not be confirmed.The reported surgical intervention and unexpected medical intervention was a result of case-specific circumstances as the valve was explanted surgically and patient was admitted.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES VALVE EXPANDED CUFF
• 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: 24272476
• Report Number: 2135147-2026-00663
• Device Sequence Number: 9947760
• Product Code: LWQ
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 06/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 33MECJ-502
• Device Catalogue Number: 33MECJ-502
• Device Lot Number: C00020589
• 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: 01/11/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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