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

Model Number	TF-19A
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	10/31/2025
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 (b)(6) 2016, a 19mm trifecta valve was implanted in the patient.On an unknown date in (b)(6) 2025, the patient had a outpatient visit and an exacerbation of aortic regurgitation (ar) was observed, but heart failure was controlled with diuretics.Due to the patient¿s age of 90 and refusal of reoperation, the case had been under observation.However, in early october, the patient presented with complaints of dyspnea and echocardiography revealed ar, mitral regurgitation (mr), and tricuspid regurgitation (tr), and reoperation was decided based on the patient¿s own will.On (b)(6) 2025, a surgical procedures performed were redo aortic valve replacement (avr) and mitral valve prolapse with tricuspid annuloplasty (mvp with tap).A new 19mm epic supra valve was implanted.A tear was observed at the junction between right coronary cusp (rcc) and non-coronary cusp (ncc).The patient was reported unstable.
Event or Problem Description
It was reported that on (b)(6) 2016, a 19mm trifecta valve was implanted in the patient.The annular dimensions of the native valve was 23mm.On an unknown date in (b)(6) 2025, the patient had a outpatient visit and an exacerbation of aortic regurgitation (ar) was observed, but heart failure was controlled with diuretics.Due to the patient¿s age of 90 and refusal of reoperation, the case had been under observation.However, in early (b)(6), the patient presented with complaints of dyspnea and echocardiography revealed ar, mitral regurgitation (mr), and tricuspid regurgitation (tr), and reoperation was decided based on the patient¿s own will.On (b)(6) 2025, a surgical procedures performed were redo aortic valve replacement (avr) and mitral valve prolapse with tricuspid annuloplasty (mvp with tap).A new 19mm epic supra valve was implanted.A tear was observed at the junction between right coronary cusp (rcc) and non-coronary cusp (ncc).The patient was reported unstable.
Additional Manufacturer Narrative
Explant about 9 post procedure due to heart failure, dyspnea, torn cusp, and aortic, mitral, and tricuspid regurgitation was reported.The valve was returned to abbott for investigation.Explant about 9 years and 4 months post procedure due to heart failure, dyspnea, torn cusp, and aortic, mitral, and tricuspid regurgitation was reported.The valve was returned to abbott for investigation.Tears were noted on cusp 1 and 3.Here was a focus of fibrous pannus ingrowth on the stent post between cusps 2 and 3.Microcalcification was observed on all three cusps.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the available information, the cause of the reported aortic, mitral, and tricuspid regurgitation could not be conclusively determined.The reported cusps tear, heart failure, renal failure, and dyspnea could not be conclusively determined.The reported hospitalization and surgical intervention were results of case-specific circumstances as the patient was admitted and 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: 23716273
• Report Number: 2135147-2025-07129
• Device Sequence Number: 8901380
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: (01)05414734052016(17)180208
• 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: 2016
• 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): 12/30/2025

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: 02/08/2018
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 5403470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2016
• 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: Other; Required Intervention; Hospitalization
• Patient Sex: Female