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

Model Number	21AGN-751
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 21mm sjm regent heart valve was chosen for a surgery of acute aortic dissection type a.They initially planned for aortic valve replacement (avr) and supra coronary ascending aortic replacement.After completing the avr procedure and while preparing for replacement of ascending aorta, surgeon found a small tear in right coronary cusp.Therefore they decided to perform bentall operation.The 21mm valve was explanted and a new 19mm sjm masters series coated aortic valved graft was implanted.
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.
Additional Manufacturer Narrative
It was reported that during procedure, a small tear in right coronary cusp was found and was therefore not implanted.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident appears to be related to damage during use.However, the exact cause could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.The reported intervention is a case specific circumstances as the valve was surgically explanted.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 24240976
• Report Number: 2135147-2026-00585
• Device Sequence Number: 9184108
• Product Code: LWQ
• UDI-Device Identifier: 05415067044297
• UDI-Public: (01)05415067044297(17)300907
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 02/26/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Device Lot Number: C00032773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 02/15/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2025
• 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: Required Intervention
• Patient Sex: Unknown