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

Model Number	TF-19A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/02/2025
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) 2021 date, a 19mm trifecta valve was implanted.On (b)(6) 2025, the patient presented with shortness of breath.Echo imaging was performed and revealed severe aortic regurgitation.The trifecta was explanted and a tear was observed along the stent between the left and right coronary cusps.A 19mm non-abbott was implanted to resolve the event.The patient has since recovered.
Event or Problem Description
It was reported that on (b)(6) 2021 date, a 19mm trifecta valve was implanted.On (b)(6) 2025, the patient presented with shortness of breath.Echo imaging was performed and revealed severe aortic regurgitation.The trifecta was explanted and a tear was observed along the stent between the left and right coronary cusps.A 19mm non-abbott was implanted to resolve the event.The patient has since recovered.
Additional Manufacturer Narrative
Explant due to torn cusp, aortic valve regurgitation, and shortness of breath was reported.The device was returned to abbott for investigation.The investigation found tear in all three cusps.Fibrous thickening was observed in cusp 1 and 3.The inflow surface has fibrous pannus ingrowth limited to the sewing cuff.The sewing cuff was disrupted in processing and the metallic ring is distorted.Microscopic examination revealed denatured appearance to the collagen at the tear site for cusp 1 and 2.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met specifications.Based on the available information, the cause of the reported aortic valve regurgitation appears to be a cascading effect of the leaflet tear.However, the cause of the leaflet tear could not be conclusively determined; however, the degenerative changes noted to the tissue at the cusps could have contributed to the leaflet tear.The cause of the pannus formation could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the device 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: 22122858
• Report Number: 2135147-2025-02897
• Device Sequence Number: 20626859
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: (01)05414734052016(17)220227
• 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): 07/09/2025

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: 02/27/2022
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: BR00015617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2018
• 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
• Patient Sex: Unknown