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

Model Number	TF-21A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Fatigue (1849)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date, a 21mm trifecta valve was implanted in the patient.On an unknown in (b)(6) 2024, the patient presented with high gradient, fatigue and shortness of breath and a structural deterioration was noted.On (b)(6) 2025, the valve was explanted and a 25mm non-abbott valve was implanted.A severe calcification and leaflet thickening with stenosis was noted on the explanted valve.The patient was reported stable.
Additional Manufacturer Narrative
The device will be 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) 2013, a 21mm trifecta valve was implanted in the patient.On an unknown in (b)(6) 2024, the patient presented with high gradient, fatigue and shortness of breath and a structural deterioration was noted.On (b)(6) 2025, the valve was explanted and a 25mm non-abbott valve was implanted.A severe calcification and leaflet thickening with stenosis was noted on the explanted valve.The patient was reported stable.
Additional Manufacturer Narrative
Explant due to device stenosis, fibrotic thickening of the leaflet, dyspnea and fatigue was reported.The device was returned to abbott for investigation.Gross examination revealed fibrous thickening and coalesced calcifications in all three cusps, leading to immobilization.Tears associated with calcifications were found in cusps 1, 2, and 3.The inflow surfaces had fibrous pannus ingrowth, while the outflow surfaces were unremarkable.Microscopic examination confirmed the presence of calcified nodules and fibrous thickening, with no signs of inflammation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the reported aortic valve stenosis is likely related to patient condition (pannus formation, calcification, and fibrous thickening).However, the cause of the pannus and calcification formation could not be conclusively determined.The cause of the tear could not be conclusively determined; however, 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 tears and reduced durability.The reported surgical intervention was a result of case-specific circumstances as the valve was explanted.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: TRIFECTA¿
• 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 #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21950141
• Report Number: 2135147-2025-02321
• Device Sequence Number: 18343022
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: (01)05414734052023(17)140821
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 05/29/2025

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 Expiration Date: 08/21/2014
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3800729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2012
• 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: 78 YR
• Patient Sex: Female