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

Catalog Number	TFGT-23A
Medical Device Problem Codes	Calcified (1077); Patient-Device Incompatibility (2682); Device Stenosis (4066)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an unknown date, a 23mm trifecta gt valve was implanted.On (b)(6) 2025, the valve was explanted due to severe and symptomatic stenosis of the valve.The stent posts were "densely adherent to the wall of the aorta for all three posts.The trifecta valve leaflets were very thickened with poor mobility and had multiple calcium deposits on all the leaflets." the patient had associated symptoms of severe shortness of breath with minimal exertion (stage iii+).The patient was reported to be doing "very well.".
Additional Manufacturer Narrative
Explant due to symptomatic stenosis, and fibrotic thickening of leaflets was reported.Investigation found the valve was completely destructed into several pieces.Biological material was noted on the valve.It was indicated that the stent posts were "densely adherent to the wall of the aorta for all three posts.Repotedly, the valve leaflets were very thickened with poor mobility and had multiple calcium deposits on all the leaflets.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met specifications.The cause of the reported stenosis appears to be related to the patient condition could not be conclusively determined.The cause of valve destructed into several pieces could not be conclusively determined; however, the calcium deposits on all the leaflets 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 tears and reduced durability.The reported surgical intervention were a result of case-specific circumstances as the valve was explanted.

• Brand Name: TRIFECTA¿ GT 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: 21480256
• Report Number: 2135147-2025-00993
• Device Sequence Number: 19863806
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: (01)05415067018229(17)210916(10)BR00014332
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 09/16/2021
• Device Catalogue Number: TFGT-23A
• Device Lot Number: BR00014332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2017
• 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 Age: 65 YR
• Patient Sex: Female