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

Model Number	TF-21A
Medical Device Problem Codes	Calcified (1077); Patient-Device Incompatibility (2682); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Arrhythmia (1721); Dyspnea (1816)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.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) 2017, a 21mm trifecta valve was implanted.On (b)(6) 2025, increased pressure gradient and valve stenosis due to pannus formation was observed alongside patient symptoms of dyspnea and palpitations.Echocardiography confirmed elevated pressure gradient.On (b)(6) 2025, the valve was explanted.Upon explant, pannus formation was observed circumferentially on the inflow side as well as pannus and valve stiffening on the outflow side; calcification was also observed.A new 23mm epic supra valve was implanted.The patient was reported to be in stable condition.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Explant due to dyspnea, palpitations, pressure gradient and valve stenosis due to pannus formation after 8 years of valve implant was reported.Also reported that upon explant circumferential pannus formation was observed on the inflow side as well as pannus and valve stiffening on the outflow side; calcification was also observed.The investigation found fibrous thickening on all leaflets which immobilized the leaflets.Leaflet 1 was torn.There was organizing fibrin thrombus adherent to the leaflet base on the outflow surface.There were calcifications with valvular stenosis.Circumferential fibrous pannus ingrowth was observed on the inflow surface with narrowing of inflow diameter.No inflammation was present.The sewing cuff was intact.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The limited mobility of the leaflets and leaflet tear associated with calcifications, further exacerbated by the thrombus and pannus ingrowth is consistent with the elevated gradient and stenosis.The reported dyspnea and palpitations appear to be cascading effects of elevated pressure gradient.The surgical intervention is a result of explant of valve.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: 22846477
• Report Number: 2135147-2025-04657
• Device Sequence Number: 20926201
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: (01)05414734052023(17)180130
• 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: 2017
• Device Explanted Year: 2025
• 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): 10/15/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2018
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 5392875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2016
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 59 KG