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

Model Number	TF-19A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Material Split, Cut or Torn (4008); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Arrhythmia (1721); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/29/2025
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) 2015, a 19mm trifecta valve was implanted in the patient.The sizing of the annular dimensions of the native valve was 24mm.On an unknown date in aug 2025, a heart murmur was noted and the patient was followed up in the outpatient clinic.On an unknown date in october, the patient reported exertional dyspnea interfering with daily life, prompting another outpatient visit and an aortic regurgitation was diagnosed by echocardiography.A surgery was performed, including redo aortic valve replacement (redo avr) and coronary artery bypass grafting (cabg) of two vessels.A 21mm epic supra valve was implanted in the patient.A pannus formation was observed on the inflow side of the valve.Approximately one-third of the right coronary cusp (rcc) is torn, and an additional tear is present at the commissure between the left coronary cusp (lcc) and the rcc.The patient was reported stable.
Event or Problem Description
It was reported that on (b)(6) 2015, a 19mm trifecta valve was implanted in the patient.The sizing of the annular dimensions of the native valve was 24mm.On an unknown date in (b)(6) 2025, a heart murmur was noted and the patient was followed up in the outpatient clinic.On an unknown date in october, the patient reported exertional dyspnea interfering with daily life, prompting another outpatient visit and an aortic regurgitation was diagnosed by echocardiography.A surgery was performed, including redo aortic valve replacement (redo avr) and coronary artery bypass grafting (cabg) of two vessels.A 21mm epic supra valve was implanted in the patient.A pannus formation was observed on the inflow side of the valve.Approximately one-third of the right coronary cusp (rcc) is torn, and an additional tear is present at the commissure between the left coronary cusp (lcc) and the rcc.The patient was reported stable.
Additional Manufacturer Narrative
Explant due to heart murmur, dyspnea and aortic regurgitation after 10 years of implant was reported.Also reported that there was torn leaflet and pannus formation observed on the inflow of the explanted valve.The investigation found that leaflets 1 and 2 were torn with degenerative changes.There was a 1 mm partial tear in the base of leaflet 3 at the stent post shared with leaflet 2.There was circumferential fibrous pannus ingrowth on the inflow surface, and on outflow surface over the stent post shared between leaflets 2 and 3.No acute inflammation or significant calcifications were present.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.In the absence of any calcification at the tear site or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did demonstrate degenerative changes and loss of collagen at the tear site.The leaflet tear could have contributed to the reported regurgitation.The reported patient effects of aortic regurgitation, dyspnea, heart murmur appear to be cascading effects.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 LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23618847
• Report Number: 2135147-2025-06785
• Device Sequence Number: 10045362
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: (01)05414734052016(17)170330
• 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: 2015
• 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): 01/20/2026

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: 03/30/2017
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: BR00002537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2015
• 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: 85 YR
• Patient Sex: Male