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

Catalog Number TFGT-25A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Fatigue (1849); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a 25mm trifecta gt valve was implanted in march of 2015.On an unknown date the patient presented with shortness of breath, dyspnea, and fatigue.The patient was diagnosed with aortic regurgitation.On 21 february 2024 a 25mm navitor transcatheter aortic valve was implanted in a patient valve in valve procedure.There were no adverse effects to the patient.The patient status was stable.

• Brand Name: TRIFECTA¿ GT VALVE
• Type of Device: 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: 18918527
• MDR Text Key: 337843218
• Report Number: 2135147-2024-01155
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018236
• UDI-Public: 05415067018236
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TFGT-25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention