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

Model Number	23AGN-751
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Dyspnea (1816); Syncope/Fainting (4411); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on 17 may 2022, a 23mm sjm regent heart valve ((b)(4)) was implanted in the aortic valve and a 31mm sjm masters series valve expanded cuff ((b)(4)) was implanted in the mitral valve during a double valve replacement.On a later date, the patient presented with shortness of breath and syncopal episodes.The aortic valve and mitral valve were both experiencing resistance or sticking.On (b)(6) 2022, another double valve replacement was performed.For the aortic valve, the 23mm sjm regent heart valve ((b)(4)) was explanted and replaced with a 21mm sjm regent heart valve ((b)(4)).For the mitral valve, the 31mm sjm masters series valve expanded cuff ((b)(4)) was explanted and replaced with a 31mm sjm masters series valve expanded cuff ((b)(4)).The patient status was reported as stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Explant due to shortness of breath, episodes of fainting were reported.The investigation found that there was limited leaflet mobility for one of the leaflets.There was a brown non-adherent material on both mechanical leaflet surfaces and the pivot recesses.The sewing cuff was intact and contained patchy fibrous pannus, which did not appear to impinge upon the leaflets.No inflammation or significant calcifications was present.The surfaces of the mechanical leaflets had fibrin and fungal hyphae.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The limited leaflet mobility could lead to a number of potential issues with valve functionality.
Event or Problem Description
It was reported that on (b)(6) 2022, a 23mm sjm regent heart valve (b)(6) was implanted in the aortic valve and a 31mm sjm masters series valve expanded cuff (b)(6) was implanted in the mitral valve during a double valve replacement.On a later date, the patient presented with shortness of breath and syncopal episodes.The aortic valve and mitral valve were both experiencing resistance or sticking.On (b)(6) 2022, another double valve replacement was performed.For the aortic valve, the 23mm sjm regent heart valve (b)(6) was explanted and replaced with a 21mm sjm regent heart valve (b)(6).For the mitral valve, the 31mm sjm masters series valve expanded cuff (b)(6) was explanted and replaced with a 31mm sjm masters series valve expanded cuff (b)(6).The patient status was reported as stable.Subsequent to the previously filed report, additional information was received that the 23mm sjm regent heart valve (b)(6) had one leaflet that was fully closed, which may have been caused by the pannus formation.For the 31mm sjm masters series mitral valve expanded cuff (b)(6), there was difficulty closing the valve completely, which may have been caused by the pannus formation.The patient's international normalized ratio (inr) was 2.9.The patient was taking the vitamin k antagonist acetrome 4mg once daily.

• 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): 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: 15451409
• Report Number: 2135147-2022-01246
• Device Sequence Number: 17643738
• Product Code: LWQ
• UDI-Device Identifier: 05414734006101
• UDI-Public: 05414734006101
• 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: 2022
• Device Explanted Year: 2022
• 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): 12/20/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2025
• Device Model Number: 23AGN-751
• Device Catalogue Number: 23AGN-751
• Device Lot Number: 7759784
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SJM MASTERS SERIES VALVE EXPANDED CUFF, 31MECJ-502; SJM REGENT HEART VALVE, 23AGN-751, SN (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 49 KG