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

Catalog Number TFGT-23A

Device Problems Degraded (1153); Material Split, Cut or Torn (4008)

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

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2020, a 23mm trifecta valve (serial: (b)(6)) was implanted.The patient had a history of severe aortic regurgitation and had a native valve annular dimension of 23mm.After three years, on (b)(6) 2024, the patient returned with grade iii dyspnea and severe aortic regurgitation.After further observation it was found that the trifecta had structural deterioration and a torn cusp.Intervention is planned but has not yet occurred.

Manufacturer Narrative

An event of dyspnea and severe aortic regurgitation about three years after the valve was implanted was reported.A more comprehensive assessment, including histopathological examination of the valve tissue, could not be performed as the device remains implanted and was not returned for analysis.It was observed that the valve had structural deterioration and a torn cusp.Echocardiogram received shows evidence of severe aortic regurgitation.Not possible to visualize whether there is a torn leaflet, but would require surgery to visualize leaflet status.Factors that may cause or contribute to valve deterioration include implant-related factors, biological factors, and patient-related factors.Patient comorbidities includes severe aortic regurgitation and had a native valve annular dimension which could have caused the reported event of valve deterioration but could not be conclusively determined.The device history record was 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 regards to manufacture, design, or labeling.H6 medical device problem code: code 1153 removed.

• 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: 18734450
• MDR Text Key: 335694632
• Report Number: 2135147-2024-00735
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: (01)05415067018229(17)230729(10)7139936
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2023
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 7139936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2019
• 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): Other; Required Intervention