MAUDE Adverse Event Report: ABBOTT MEDICAL Regent Heart Valve; Heart-Valve, Mechanical

Model Number	23AGN-751
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
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) 2025, an unknown regent heart valve was chosen for a procedure.During procedure, the valve detached and stuck in the patients groin.The patient had severe aortic insufficiency due to the missing leaflet and consequently required an impella.The patient was reported critical.
Additional Manufacturer Narrative
An event of a dislodged leaflet and patient effect of central regurgitation was reported.The device was returned to abbott for analysis.The investigation found that the dislodged leaflet was not returned and chipped surface was noted on the orifice rim.Due to this functional test was precluded.No other anomalies were observed.A dhr review was not performed as the lot number was not provided from the field.The cause of the reported event could not be conclusively determined.However, it is consistent with an external force being applied to the valve or an attempt to rotate the valve.The reported unexpected medical intervention is a case specific circumstances as patient required impella.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, an unknown regent heart valve was chosen for a procedure.During procedure, the valve detached and stuck in the patients groin.The patient had severe aortic insufficiency due to the missing leaflet and consequently required an impella.The patient was reported critical.
Event or Problem Description
It was reported that on (b)(6) 2025, a 23mm regent heart valve was chosen for a procedure.During procedure, the valve detached and stuck in the patients groin.The patient had severe aortic insufficiency due to the missing leaflet and consequently required an impella.The patient was reported critical.On (b)(6) 2026, the patient was reported passed away.
Additional Manufacturer Narrative
An event of a dislodged leaflet and patient effect of central regurgitation was reported.The device was returned to abbott for analysis.The investigation found that the dislodged leaflet was not returned and chipped surface was noted on the orifice rim.Due to this functional test was precluded.No other anomalies were observed.A medical review was performed by an abbott representative; "the exact details of the implant procedure are unknown such that it is not possible to determine the exact cause for the dislodged leaflet.A dislodged leaflet is a known potential adverse event that may occur during or after a mhv implant.A common cause for a mhv leaflet dislodgement or leaflet fracture may be related to a forceful valve insertion due to oversizing and/or inappropriate use of the valve holder/rotator or inappropriate use of instruments while implanting or attempting to rotate the valve.In this case it is not possible to determine the exact cause for the dislodged leaflet.Examination of the returned mhv confirms that one of the leaflets is missing.There is some evidence for surface scratches on the orifice of the valve that may be indicative of instrumentation used at the time of valve implant or explant.There is no evidence for a fracture or damage to the remaining leaflet.The patient developed intra-operative hemodynamic instability which was managed with insertion of an impella.It is unknown if the mvh was replaced with another valve but presumed to have undergone explant.It is also unknown if the missing leaflet was retrieved.The patient likely had a prolonged procedure and had difficulty recovering following surgery which ultimately led to the fatality 3 weeks later.The cause of death is procedure related and is unlikely to be related to a device malfunction." the device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.The cause of the reported event could not be conclusively determined.The reported unexpected medical intervention is a case specific circumstances as patient required impella.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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 ; PR 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 23966812
• Report Number: 2135147-2026-00076
• Device Sequence Number: 15788499
• Product Code: LWQ
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 08/06/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 23AGN-751
• Device Catalogue Number: 23AGN-751
• Device Lot Number: C00033429
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/27/2026
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 02/17/2026; 07/16/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/02/2026; 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• 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: Death; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male