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

Model Number	TFGT-A
Medical Device Problem Codes	Degraded (1153); Perivalvular Leak (1457)
Health Effect - Clinical Codes	Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: (b)(4) -trifecta gt pmcf, patient site id: (b)(6).It was reported that on (b)(6) 2018, a 19mm trifecta gt valve was successfully implanted due to aortic stenosis of the native valve.On (b)(6) 2018, a post procedure echocardiogram was performed and showed mild paravalvular aortic regurgitation.During the six-month follow-up appointment, no regurgitation was observed.On (b)(6) 2023, it was confirmed that structural valve deterioration had occurred on the trifecta valve due to decreased leaflet mobility.No intervention was provided.The patient continues to be followed in the clinical study.
Additional Manufacturer Narrative
An event of mild paravalvular aortic regurgitation post procedure and structural valve deterioration due to decreased leaflet mobility was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, which confirmed the temperature indicator was not activated prior to release from abbott.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
Clinical information: (b)(6) - trifecta gt pmcf, patient site id: (b)(6).It was reported that on (b)(6) 2018, a 19mm trifecta gt valve was successfully implanted due to aortic stenosis of the native valve.On (b)(6) 2018, a post procedure echocardiogram was performed and showed mild paravalvular aortic regurgitation.The max velocity was recorded at 4.55m/s, the max gradient was 55 mmhg, and mid-gradient was 55mmhg.During the six-month follow-up appointment, no regurgitation was observed.On (b)(6) 2023 during a scheduled test, it was confirmed that structural valve deterioration had occurred on the trifecta valve due to decreased leaflet mobility.The patient's dyspnea progressed to new york heart association (nyha) ii.No intervention was provided.The patient continues to be followed in the clinical study.

• Brand Name: TRIFECTA¿ GT VALVE
• 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: 16781869
• Report Number: 2135147-2023-01746
• Device Sequence Number: 6397886
• Product Code: LWR
• UDI-Device Identifier: 05415067018205
• UDI-Public: 05415067018205
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2021
• Device Model Number: TFGT-A
• Device Catalogue Number: TFGT-19A
• Device Lot Number: 6086615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2017
• 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
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: White