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

Model Number	21AGN-751
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/27/2025
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, a 21mm regent valve was successfully implanted.Post-implant, intraoperative transesophageal echocardiography (tee) revealed a moderate paravalvular leak (pvl) at the left coronary cusp (lcc) region.It was decided to replace the valve with another 21mm regent valve.Upon explantation of the aortic prosthesis, a defect in the peri-membranous septum was identified beneath the valve annulus, which was the likely cause of the pvl.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient is stable.
Additional Manufacturer Narrative
An event of perivalvular leak was reported.A more comprehensive assessment could not be performed as the device was received for analysis.Information from field indicated that defect in the peri-membranous septum was identified beneath the valve annulus, which was the likely cause of the pvl.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.The reported surgical intervention was the result of case-specific circumstances, as device was surgical explanted.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, a 21 mm regent valve was successfully implanted.Post-implant, intraoperative transesophageal echocardiography (tee) revealed a moderate paravalvular leak (pvl) at the left coronary cusp (lcc) region.It was decided to replace the valve with another 21 mm regent valve.Upon explantation of the aortic prosthesis, a defect in the peri-membranous septum was identified beneath the valve annulus, which was the likely cause of the pvl.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient is stable.

• 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: 22308439
• Report Number: 2135147-2025-03367
• Device Sequence Number: 8706089
• Product Code: LWQ
• UDI-Device Identifier: 05415067044297
• UDI-Public: (01)05415067044297(17)290507
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 07/18/2025

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: C00020953
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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: Required Intervention
• Patient Sex: Unknown