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

Model Number	19AGN-751
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
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 19mm sjm regent heart valve was chosen for a procedure.During procedure, the leaflet came out and went left ventricle.
Additional Manufacturer Narrative
An event of leaflet fracture during implantation was reported.The device was returned to abbott for analysis.The investigation confirmed the valve was returned with a fractured leaflet.Meanwhile, the other leaflet remained intact with mobility.The valve was able to rotate freely.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 root cause of the leaflet fracture could not be conclusively determined as there was no evidence of material defect in the carbon coating that may have caused or contributed to the fractured leaflet.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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 19mm sjm regent heart valve was chosen for a procedure.During procedure, the leaflet came out and went left ventricle.They confirmed the intact leaflet was recovered from the patient.The valve got removed and replaced with another valve while patient on bypass.The patient was reported discharged.

• Brand Name: REGENT 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: 24808722
• Report Number: 2135147-2026-02226
• Device Sequence Number: 21199729
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: (01)05414734005869(17)300826
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/15/2026

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: 19AGN-751
• Device Catalogue Number: 19AGN-751
• Device Lot Number: C00032546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• 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