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

Model Number	23AGFN-756
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/11/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
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) 2025, a regent implant procedure occurred.During the procedure, the chief surgeon sutured an artificial blood vessel and enlarged the root of the aortic valve annulus.Subsequently, the chief surgeon measured the size of the annulus using standard methods and decided to implant the 23mm regent mechanical valve.After suturing, it was found that the valve leaflets could not be fully opened.The chief surgeon replaced the valve with another brand of mechanical valve to complete the implantation.There were some correlations with hemodynamic instability and procedural delay due to the leaflet issue.After the surgery, on the same day, the patient died due to a ruptured heart.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.They believe the patient's postoperative death is related to the non-abbott valve, the procedure, or the patient's comorbidities.
Additional Manufacturer Narrative
An event of perforation, valve leaflets not opening and closing during implant and patient death was reported.The device was returned to abbott for investigation.No anomalies were found with the valve leaflets with both leaflets able to fully open and close without resistance.The valve was able to be rotated without difficulty.Hydrodynamic examination indicated the valve met functional specification.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including functional testing, and the product met all specifications.The exact cause of the incomplete coaptation could not be conclusively determined.The cause of patient's postoperative death is related to the non-abbott valve, the procedure, or the patient's comorbidities.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.From medical review: the cause of death is procedure related due to a ruptured heart which most likely caused significant bleeding with the need for emergency intervention and difficulty rescuing the patient which ultimately led to the death.Bleeding from the aortic suture line following an aortic annular enlargement procedure is a known potential complication.Although additional surgery time was required to replace the regent 23mm mhv, it is unlikely to have caused the reported cardiac rupture, particularly since the regent valve was removed and a non-abbott mhv was subsequently implanted.The difficulty in the opening of the regent 23mm valve leaflets most likely was a result of oversizing.
Event or Problem Description
It was reported that on (b)(6) 2025, a regent implant procedure occurred.During the procedure, the chief surgeon sutured an artificial blood vessel and enlarged the root of the aortic valve annulus.Subsequently, the chief surgeon measured the size of the annulus using standard methods and decided to implant the 23mm regent mechanical valve.After suturing, it was found that the valve leaflets could not be fully opened.The chief surgeon replaced the valve with another brand of mechanical valve to complete the implantation.There were some correlations with hemodynamic instability and procedural delay due to the leaflet issue.After the surgery, on the same day, the patient died due to a ruptured heart.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.They believe the patient's postoperative death is related to the non-abbott valve, the procedure, or the patient's comorbidities.

• 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: 22002054
• Report Number: 2135147-2025-02495
• Device Sequence Number: 9099689
• Product Code: LWQ
• UDI-Device Identifier: 05415067044174
• UDI-Public: (01)05415067044174(17)290806
• 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: 2025
• Device Explanted Year: 2025
• 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): 06/25/2025

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: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: C00022947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2024
• 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: Hospitalization; Death
• Patient Sex: Unknown