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

Model Number	TFGT-19A
Medical Device Problem Codes	Calcified (1077); Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Arrhythmia (1721); Atrial Fibrillation (1729); Heart Failure/Congestive Heart Failure (4446)
Date of Event	06/12/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2017, a 19mm trifecta gt valve was implanted for aortic stenosis.On an unknown date, a pacemaker was implanted for atrioventricular (av) conduction problems.In addition, the patient experienced supraventricular arrhythmias and atrial fibrillation (af) and they were anticoagulated for paroxysmal af.On another unknown date following, an echocardiography was conducted and indicated the left ventricular ejection fraction (ef) was below normal range.Due to low ef, on (b)(6) 2024, the valve was explanted and replaced with a 23mm non-abbott valve.It was noted that the trifecta valve was very stiff with calcific plaque on the valve leaflets causing restricted leaflet motion.
Additional Manufacturer Narrative
Based on the information received, the reported event is consistent with structural valve deterioration (svd), specifically fibro-calcific svd (fcsvd), which is a well-known complication of tissue heart valve replacement surgery.A variety of factors may contribute to svd, including patient, biological, and implant related factors.Biological factors which can result in incomplete coaptation such as calcification, immobilizing thrombus, or pannus formation reducing the valve diameter also could not be confirmed as the valve was not returned for histopathological examination.Operative notes were reviewed and tee demonstrated good ventricular function at the end of the trifecta implant case with the aortic valve prosthesis to be well seated without perivalvular leak.There was no significant mitral insufficiency.Findings from explant operative notes determined the aortic valve prosthesis was very stiff with calcific plaque on the valve leaflets causing restricted leaflet motion.The left coronary button had mild atherosclerotic changes.During direct custodial infusion in the right coronary artery there was a small tear noted in the left lateral side of the rca.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2017, a 19 mm trifecta gt valve was implanted for aortic stenosis.On an unknown date, a pacemaker was implanted for atrioventricular (av) conduction problems.In addition, the patient experienced supraventricular arrhythmias and atrial fibrillation (af) and they were anticoagulated for paroxysmal af.On another unknown date following, an echocardiography was conducted and indicated the left ventricular ejection fraction (ef) was below normal range.Due to low ef, on (b)(6) 2024, the valve was explanted and replaced with a 23 mm non-abbott valve.It was noted that the trifecta valve was very stiff with calcific plaque on the valve leaflets causing restricted leaflet motion.The patient was reported passed away on an unknown date.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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 #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: 20487411
• Report Number: 2135147-2024-05195
• Device Sequence Number: 3615104
• Product Code: LWR
• UDI-Device Identifier: 05415067018205
• UDI-Public: (01)05415067018205(17)190213
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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): 06/17/2026

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: 02/13/2019
• Device Model Number: TFGT-19A
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 5883394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2017
• 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: Hospitalization; Required Intervention; Death
• Patient Age: 69 YR
• Patient Sex: Female