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

Model Number	TFGT-A
Medical Device Problem Codes	Degraded (1153); Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that in (b)(6) 2019, a 29mm trifecta gt valve was implanted.The patient later presented with symptoms of severe aortic regurgitation.The patient underwent a transcatheter aortic valve implantation on (b)(6) 2022, and a 29mm non-abbott valve was implanted within the trifecta valve.No additional information was provided.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Implant date has been estimated to (b)(6) 2019.
Additional Manufacturer Narrative
An event of regurgitation was reported.A returned device assessment and histopathological examination could not be performed as the device remains implanted as a valve-in-valve procedure was performed and the device was not returned for analysis.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.H6 health effect - clinical code 4449 was removed and code 4450 was added h6 medical device problem code 1153 was removed and code 2507 was added.
Event or Problem Description
It was reported that in(b)(6).2019, a 29mm trifecta gt valve was implanted.The patient later presented with symptoms of severe aortic regurgitation.The patient underwent a transcatheter aortic valve implantation on 14 april 2022, and a 29mm non-abbott valve was implanted within the trifecta valve via valve-in-valve procedure.

• 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: 14426950
• Report Number: 2135147-2022-00285
• Device Sequence Number: 6530404
• Product Code: LWR
• UDI-Device Identifier: 05415067018250
• UDI-Public: 05415067018250
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

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: 05/27/2022
• Device Model Number: TFGT-A
• Device Catalogue Number: TFGT-29A
• Device Lot Number: 6500985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2018
• 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: 75 YR
• Patient Sex: Male