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

Model Number	TF-23A
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that in 2014, a 23mm trifecta valve was implanted.On (b)(6) 2025, a 23mm navitor valve was selected for implant in an off-label use.The navitor was going to be implanted within the 23mm trifecta valve.A pre-dilation was performed with a 22mm balloon.The navitor was able to be successfully implanted and the same balloon used for the pre-dilation was used to post-dilate the valve.The result was excellent.There was no gradient and no pvl.The healthcare professional doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.
Additional Manufacturer Narrative
An event of shortness of breath, difficulty urinating, extreme fatigue, and defective device was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the available information, the cause of the reported general structural valve deterioration could not be conclusively determined.The reported surgery was the result of case-specific circumstances.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that in 2014, a 23mm trifecta valve was implanted.On (b)(6) 2025, a 23mm navitor valve was selected for implant in an off-label use.The navitor was going to be implanted within the 23mm trifecta valve.A pre-dilation was performed with a 22mm balloon.The navitor was able to be successfully implanted and the same balloon used for the pre-dilation was used to post-dilate the valve.The result was excellent.There was no gradient and no pvl.The healthcare professional doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.

• 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: 21652683
• Report Number: 2135147-2025-01428
• Device Sequence Number: 18012419
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: (01)05414734052030(17)160325
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 05/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2016
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: 4574784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2014
• 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 Age: 81 YR
• Patient Sex: Female