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

Catalog Number	TFGT-23A
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Shock (2072); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Respiratory Insufficiency (4462)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2018, a 23mm trifecta valve was implanted in the patient.After the procedure, patient having exertional weakness, fatigue and dyspnea and required hospitalization for acute congestive heart failure.On (b)(6) 2023, an echocardiography demonstrated mild-medium aortic insufficiency due to valve dysfunction and the patient presented with cardiogenic shock and respiratory failure.A transcatheter transfemoral aortic valve implantation was performed and a 26mm non-abbott valve was implanted.The patient was retuned to the v-critical care unit in critical condition.
Additional Manufacturer Narrative
An event of cardiogenic shock, aortic valve insufficiency, congestive heart failure, respiratory insufficiency, fatigue, and dyspnea was reported.Further review of the information provided indicated that the patient had progressive exertional weakness, fatigue, and dyspnea, which recently occurred at rest requiring hospitalization for acute congestive heart failure.Echocardiography demonstrated torrential aortic insufficiency due to bioprosthetic valve dysfunction and mild-to-moderate mitral insufficiency with reduced left ventricular function.The patient subsequently developed respiratory failure, requiring endotracheal intubation and increasing inotropic support.A transcatheter transfemoral aortic valve implantation procedure was performed (valve-in-valve).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 received, the cause of the reported incidents could not be conclusively determined.The reported hospitalization and surgical intervention were a result of case-specific circumstances as the patient underwent a transcatheter valve implantation (valve-in-valve).There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 20487320
• Report Number: 2135147-2024-05192
• Device Sequence Number: 17023921
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: (01)05415067018229(17)220625(10)6545821
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2022
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 6545821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2018
• 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; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female