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

Catalog Number	23AGFN-756
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 01 february 2024, a 23mm sjm regent mechanical heart valve was chosen for a aortic valve replacement (avr) procedure.The annulus was 21mm.The valve was implanted.On an unknown date, it was noted that the valve was not closing properly and severe aortic regurgitation (ar) as a result.On 09 february 2024, 8 days after the implant procedure the valve was explanted and a redo avr was performed with a new 23mm valve by another surgeon.The physician mentioned there was no problem with the valve and there had been inadequate debridement of the annulus below one of the hinges and no thrombus was noted.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of a valve not opening and closing properly was reported.Information from the field indicated that there had been inadequate debridement of the annulus below one of the hinges.The device was returned to abbott for investigation and leaflet function was considered normal with all leaflets opening while having no asynchronous motion or leaflet malfunction.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.There was no allegation of malfunction against the valve.Based on the information received the cause of the reported event, could not conclusively be determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18837220
• Report Number: 2135147-2024-00987
• Device Sequence Number: 20628419
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: (01)05414734006095(17)280805(10)C00014146
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/22/2024

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 Catalogue Number: 23AGFN-756
• Device Lot Number: C00014146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male