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

Catalog Number TFGT-23A

Device Problem Degraded (1153)

Patient Problems Angina (1710); Dyspnea (1816)

Event Date 01/17/2024

Event Type  Injury  

Event Description

It was reported that in november 2018, a 23mm trifecta gt valve was implanted during an aortic valve replacement.On (b)(6) 2024, the patient underwent additional procedure due to degradation of the valve.The patient presented with dyspnea and chest tightness with exertion.The valve was explanted.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Explant due to degradation of the valve, dyspnea and chest tightness with exertion was reported.The investigation found calcifications on all leaflets with limited leaflet mobility.Leaflets 2 and 3 were torn, associated with calcifications.There was fibrous pannus ingrowth on the outflow surface of leaflet 1 and on the inflow surface of all leaflets.There was fibrous thickening on all leaflets.No inflammation was present.The cause of the reported event could not be conclusively determined, the pannus ingrowth impeding leaflet mobility could lead to a number of potential issues with valve functionality.

• 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: 18711752
• MDR Text Key: 335474546
• Report Number: 2135147-2024-00676
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TFGT-23A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Other; Required Intervention