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

Model Number	TF-21A
Medical Device Problem Codes	Calcified (1077); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2014, a 21mm trifecta valve was successfully implanted in a patient.On an unknown date in (b)(6) 2025, the patient was diagnosed with severe aortic valve stenosis.The patient was experiencing shortness of breath and numerical data from the echocardiogram confirmed the condition.On (b)(6) 2025, the decision was made to explant the 21mm trifecta valve and replace it with a 21mm epic plus supra valve.The cause of aortic stenosis is attributed to calcification of the valve leaflets.The explanted calcified valve had a part of the leaflet removed during explant due to being calcified.The patient was stable at the time of report.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Explant about 10 years and 7 months post-procedure due to aortic valve stenosis, calcification, and dyspnea was reported.The device was returned to abbott for investigation and found all cusps to contain tears.All three cusps were noted to have fibrous thickening and calcification with valvular stenosis.There was fibrous pannus ingrowth, inflow surface, circumferential, with narrowing of inflow diameter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met specifications.The cause of the reported dyspnea appears to be a cascading effect of the reported aortic valve stenosis.The cause of the reported aortic valve stenosis appears to be related to biological factors (pannus formation, calcification, and fibrous thickening).However, the cause of the pannus and calcification formation could not be conclusively determined.The cause of the cusp tear could not be conclusively determined.The fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.The reported hospitalization and surgical intervention were results of case-specific circumstances as the patient was admitted explanting the valve and implant another valve.

• 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: 22495113
• Report Number: 2135147-2025-03833
• Device Sequence Number: 8094088
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: (01)05414734052023(17)151126
• 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 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): 09/16/2025

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: 11/26/2015
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 4489653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2013
• 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; Hospitalization
• Patient Sex: Unknown