MAUDE Adverse Event Report: ABBOTT MEDICAL SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number	TF-23A
Medical Device Problem Codes	Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2015, a 23mm trifecta valve was implanted during an aortic valve replacement.On (b)(6) 2023, the valve was noted to have stenosis and regurgitation due to valve leaflet stiffness.The valve was suspected to have structural valve deterioration (svd).The valve was explanted and replaced with a 23mm epic supra valve.The patient was later discharged.
Additional Manufacturer Narrative
An event of stenosis and regurgitation due to valve leaflet stiffness was reported.It was reported that the valve was explanted due to suspicion of structural valve deterioration (svd).The investigation found circumferential fibrous pannus ingrowth with narrowing of inflow diameter.There was fibrous thickening on all leaflets.Calcifications present on leaflets 1 and 3.D.Leaflet 3 was torn with degenerative changes at the tear site.No acute inflammation was present.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the leaflet tear could not be conclusively determined; however, the degenerative changes noted to the tissue could have contributed to the tear formation.In addition, the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tear and reduced durability.The calcifications noted could have contributed to the reported stenosis.

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18744170
• Report Number: 2135147-2024-00776
• Device Sequence Number: 15015134
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: (01)05414734052030(17)260420(10)4681816
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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 Expiration Date: 04/20/2026
• Device Catalogue Number: TF-23A
• Device Lot Number: 4681816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2014
• 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; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male