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

Model Number	TF-23A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Heart Failure/Congestive Heart Failure (4446)
Date of Event	05/01/2024
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.B3 - the event date is estimated as the actual event date could not be determined despite efforts to obtain the information.
Event or Problem Description
It was reported that on (b)(6) 2015, a 23mm trifecta valve was successfully implanted in a patient with a history of aortic stenosis.On an unknown day in (b)(6) 2024, it was noted via echocardiogram that the patient showed an increased aortic valve gradient, an aortic valve velocity of 4m/s, and reduced ejection fraction of 55%.There was no noted aortic regurgitation present, but rather hardening of the valve leaflets.The decision was made to explanted the 23mm trifecta valve and replace it with a 23mm non-abbott device.The valve was successfully explanted a replaced without handling the valve with any unprotected forceps or sharp instruments.The explanted 23mm trifecta valve had no tear observed in the leaflets or suture cuff.However, the cusp was found to have fibrosis.The patient have chronic renal insufficiency.The patient was stable at the time of report.
Additional Manufacturer Narrative
An event of aortic stenosis and valve explanted was reported.Also reported that valve was replaced with non-abbott valve.The device was returned to abbott and the investigation found that biological material and blood/body fluids were present throughout the valve.The leaflets had limited mobility when manually manipulated.The valve was found to have fibrosis, pannus, and calcification.There was no noted interaction between any stent post and patient anatomy.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 event could not be conclusively determined.The cause of the reported stenosis may be related to the pannus and calcification formation.However, the cause of the pannus and calcification formation could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the device had to be 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 north; 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21773819
• Report Number: 2135147-2025-01734
• Device Sequence Number: 8073325
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: (01)05414734052030(17)170425
• 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): 05/28/2025

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: 04/25/2017
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: BR00002853
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2015
• 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: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female