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

Model Number	TF-19A
Medical Device Problem Codes	Incomplete Coaptation (2507); Patient-Device Incompatibility (2682); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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.On an unknown date in (b)(6) 2025, the patient visited the hospital due to suspected heart failure.The sizing of the annular dimensions of the native valve was 20mm.A coronary angiogram (cag) revealed stenosis in left anterior descending artery (lad) and right coronary artery (rca).Based on ultrasound examination, the blood flow velocity was noted to be high, therefore, the patient was also diagnosed with aortic stenosis.On (b)(6) 2025, a procedure was performed as the patient reported dyspnea on exertion.The valve was explanted and a new 19mm epic plus supra valve was implanted.A pannus was noted circumferentially on the outflow side of the explanted trifecta valve.Additionally, pannus was noted on inflow side, and the leaflet corresponding to the left coronary cusp (lcc) was completely calcified and immobile.The patient was reported stable.
Additional Manufacturer Narrative
Explant due to aortic valve stenosis, pannus formation, leaflet incomplete coaptation, and shortness of breath was reported.The device was returned to abbott for investigation and found all cusps to contain tears, calcification and fibrous thickening.There was fibrous pannus ingrowth noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the reported aortic valve stenosis and incomplete coaptation appears to be related to the patient condition (pannus formation, calcification, and fibrous thickening).However, the cause of the pannus and calcification formation could not be conclusively determined.The cause of the tear could not be conclusively determined.The reported hospitalization and surgical intervention were results of case-specific circumstances as the patient was admitted, the valve was explanted, and a replacement valve was implanted.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: 22167296
• Report Number: 2135147-2025-03033
• Device Sequence Number: 9209313
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: (01)05414734052016(17)170413
• 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): 07/21/2025

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: 04/13/2017
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: BR00002773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2015
• 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: 79 YR
• Patient Sex: Female