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

Catalog Number	TFGT-21A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/28/2023
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) 2016, a 21mm trifecta gt final package - wr was implanted in a patient.The implantation was successful and the device functioned until it suddenly stopped functioning in (b)(6) 2023.At that time, the patient began experiencing extreme fatigue, heart palpitations, and shortness of breath.A cardiac angiogram was performed which demonstrated significant aortic regurgitation due to malfunctioning flaps on the valve.A removal and replacement of the device was scheduled immediately thereafter.The removal and replacement procedure took place on (b)(6) 2023.The valve was replaced with a non-abbott device.The patient is stable, no additional information was provided.
Additional Manufacturer Narrative
An event of extreme fatigue, heart palpitations, and shortness of breath was reported.A cardiac angiogram was performed that demonstrated significant aortic regurgitation due to malfunctioning flaps on the valve.It was reported that a 21 mm trifecta valve was implanted in the patient in (b)(6) 2016.The implantation was successful, and the device functioned until (b)(6) 2023.The valve was explanted and replaced with a non-abbott valve in (b)(6) 2023, and the patient was reported as stable.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.However, based on the information received, the reported event is consistent with structural valve deterioration (svd), which is a well-known complication of tissue heart valve replacement surgery.A variety of factors may contribute to svd, including patient, biological, and implant related factors.Reportedly, the valve implantation was successful with limited implant-related information.Biological factors which can result in tissue degeneration such as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.) or thinning of the prosthetic leaflet tissue (predisposing to leaflet tears) could not be confirmed as the valve was not returned for histopathological examination.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Correction to section e.Initial reporter.

• 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: 19558887
• Report Number: 2135147-2024-02863
• Device Sequence Number: 6711754
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2018
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 5394488
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2016
• 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