MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART COATED AORTIC VALVED GRAFT; HEART-VALVE, MECHANICAL

Model Number	21CAVGJ-514 00
Medical Device Problem Codes	Perivalvular Leak (1457); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/12/2025
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 masters series heart coated aortic valved graft was successfully implanted in a patient.The annular dimensions of the patient's native aortic valve were not given.There was no difficulty experienced attempting to implant the 21mm masters series heart coated aortic valved graft.Post-procedure, it was noted that the patient had aortic regurgitation.The decision was made explant the 21mm masters series heart coated aortic valved graft and replace it was a 21mm regent heart valve with flex cuff and non-abbott graft device.The patient was removed off cardiopulmonary bypass (cpb) and then put back on cpb for further intervention.There was a clinically significant delay in procedure, but the patient was medically managed.The patient did not have any other clinical signs or symptoms after this event and no initial or prolonged hospitalization.The cause of the aortic regurgitation is related to a notable perivalvular leak of the 21mm masters series heart coated aortic valved graft.The patient was stable at the time of report.
Additional Manufacturer Narrative
An event of regurgitation post-procedure and perivalvular leak were reported.Also noted that the cause of the aortic regurgitation is related to a notable perivalvular leak due to abbott valve.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.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 incidents could not conclusively be determined.The reported surgical intervention was under case specific circumstances as device was removed surgically.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES HEART COATED AORTIC VALVED GRAFT
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22157950
• Report Number: 2135147-2025-02953
• Device Sequence Number: 8683660
• Product Code: LWQ
• UDI-Device Identifier: 05414734006026
• UDI-Public: (01)05414734006026(17)290507
• 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: 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): 06/18/2025

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: 21CAVGJ-514 00
• Device Catalogue Number: 21CAVGJ-514 00
• Device Lot Number: 10336396
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 06/18/2025
• 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