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

Model Number	19AGFN-756
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
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 w/ flex cuff was chosen for a aortic valve replacement (avr) surgery.During procedure, after sizing when the valve was being placed (during cuff ligation), an abnormality of the leaflet was visually observed.Upon inspection, the leaflet was found to be damaged and detached from the valve.Prior to the visual confirmation of the abnormality, the leaflet portion had not been touched.The valve was removed and a new 17mm sjm regent heart valve w/ flex cuff was implanted while patient on bypass.The patient was reported stable.
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 orifice was observed to be fractured and contained a chip damage from top and bottom rim.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 w/ flex cuff was chosen for a aortic valve replacement (avr) surgery.During procedure, after sizing when the valve was being placed (during cuff ligation), an abnormality of the leaflet was visually observed.Upon inspection, the leaflet was found to be damaged and detached from the valve.Prior to the visual confirmation of the abnormality, the leaflet portion had not been touched.The valve was removed and a new 17mm sjm regent heart valve w/ flex cuff was implanted while patient on bypass.The patient was reported stable.

• Brand Name: REGENT HEART VALVE WITH FLEX 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: 24911077
• Report Number: 2135147-2026-02478
• Device Sequence Number: 21131167
• Product Code: LWQ
• UDI-Device Identifier: 05415067042934
• UDI-Public: (01)05415067042934(17)291003
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 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: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: C00024555
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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
• Patient Age: 54 YR
• Patient Sex: Female