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

Model Number	TFGT-25A
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Dyspnea (1816); Fatigue (1849); Renal Failure (2041); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2017, a 25mm trifecta valve was implanted for aortic valve replacement procedure.The immediate postoperative course was uneventful, and early follow-up demonstrated significant improvement in cardiac function, with ejection fraction rising to 45¿50% and the prosthesis functioning normally.On (b)(6) 2019, an echocardiography (ecg) performed and confirmed stable performance, with normal transvalvular gradients and no evidence of structural deterioration.On (b)(6) 2025, the patient was hospitalized for the onset of progressively worsening exertional dyspnea over several months, along with asthenia, easy fatigability, and loss of appetite.The patient got admitted in to the hospital.The ecg showed atrial fibrillation with a ventricular response of 80 bpm.The chest computed tomography (ct) revealed signs of chronic bronchopulmonary disease and no mediastinal collections.Echocardiography initially suggested a periprosthetic leak due to partial detachment of the prosthesis (a finding later not confirmed by subsequent, more accurate examinations).The prosthesis was described as ¿in place with normal transvalvular gradients, left ventricle moderately hypokinetic (ef 38%).¿ laboratory tests indicated possible stage ii chronic renal insufficiency (creatinine 1.32 mg/dl).On (b)(6) 2020, the patient was transferred to the cardiac surgery department, where transthoracic and transesophageal echocardiography revealed the following: a slightly dilated and hypertrophic left ventricle, a severely dilated left atrium, mild mitral regurgitation due to annular dilation, and the trifecta valve in place but showing degeneration and abnormal motion of the non-coronary cusp, resulting in severe intra-prosthetic regurgitation.That failure necessitated urgent reintervention via transcatheter valve-in-valve implantation (tavi), as conventional surgery posed prohibitive risk given the patient¿s frailty and comorbidities.On 31 july 2020, the patient underwent a tavi procedure via the right femoral and right radial approach, with implantation of a 26mm non-abbott valve using a valve-in-valve technique.The procedure was completed without complications.On (b)(6) 2020, following an uneventful post-tavi course, the patient was discharged in good hemodynamic and metabolic condition, with vascular access sites healing.Pre-discharge echocardiography confirmed biatrial dilation, mild mitral regurgitation, left ventricular dilation with wall thickening and good contractility (ef 50%).The aortic bio prosthesis was competent, with normal maximum/mean gradients (11/7 mmhg).
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 (b)(6) 2017, a 25mm trifecta valve was implanted for aortic valve replacement procedure.The immediate postoperative course was uneventful, and early follow-up demonstrated significant improvement in cardiac function, with ejection fraction rising to 45¿50% and the prosthesis functioning normally.On (b)(6) 2019, an echocardiography (ecg) performed and confirmed stable performance, with normal transvalvular gradients and no evidence of structural deterioration.On (b)(6) 2025, the patient was hospitalized for the onset of progressively worsening exertional dyspnea over several months, along with asthenia, easy fatigability, and loss of appetite.The patient got admitted in to the hospital.The ecg showed atrial fibrillation with a ventricular response of 80 bpm.The chest computed tomography (ct) revealed signs of chronic bronchopulmonary disease and no mediastinal collections.Echocardiography initially suggested a periprosthetic leak due to partial detachment of the prosthesis (a finding later not confirmed by subsequent, more accurate examinations).The prosthesis was described as ¿in place with normal transvalvular gradients, left ventricle moderately hypokinetic (ef 38%).¿ laboratory tests indicated possible stage ii chronic renal insufficiency (creatinine 1.32 mg/dl).On (b)(6) 2020, the patient was transferred to the cardiac surgery department, where transthoracic and transesophageal echocardiography revealed the following: a slightly dilated and hypertrophic left ventricle, a severely dilated left atrium, mild mitral regurgitation due to annular dilation, and the trifecta valve in place but showing degeneration and abnormal motion of the non-coronary cusp, resulting in severe intra-prosthetic regurgitation.That failure necessitated urgent reintervention via transcatheter valve-in-valve implantation (tavi), as conventional surgery posed prohibitive risk given the patient¿s frailty and comorbidities.On (b)(6) 2020, the patient underwent a tavi procedure via the right femoral and right radial approach, with implantation of a 26mm non-abbott valve using a valve-in-valve technique.The procedure was completed without complications.On (b)(6) 2020, following an uneventful post-tavi course, the patient was discharged in good hemodynamic and metabolic condition, with vascular access sites healing.Pre-discharge echocardiography confirmed biatrial dilation, mild mitral regurgitation, left ventricular dilation with wall thickening and good contractility (ef 50%).The aortic bio prosthesis was competent, with normal maximum/mean gradients (11/7 mmhg).
Additional Manufacturer Narrative
An event of central regurgitation and structural valve deterioration was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The reported surgical interventions and hospitalization were a resulted of case-specific circumstances, as valve-in-valve implantation was performed.Based on the information received, a cause for the reported central regurgitation and structural valve deterioration could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 23882571
• Report Number: 2135147-2025-07643
• Device Sequence Number: 4669299
• Product Code: LWR
• UDI-Device Identifier: 05415067018236
• UDI-Public: (01)05415067018236(17)210326
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 01/14/2026

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: 03/26/2021
• Device Model Number: TFGT-25A
• Device Catalogue Number: TFGT-25A
• Device Lot Number: 5950523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2017
• 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; Other
• Patient Sex: Unknown