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

Catalog Number TFGT-21A

Device Problems Calcified (1077); Incomplete Coaptation (2507); Central Regurgitation (4068)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/22/2024

Event Type  Death  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that in 2020, a 21mm trifecta gt valve was implanted during an aortic valve replacement.In (b)(6) 2023, the patient presented to the hospital with structural valve deterioration (svd) and evidence of aortic valve regurgitation with at least one leaflet collapsed.On (b)(6) 2024, the patient was admitted to the hospital with a plan to undergo a redo aortic valve replacement.On (b)(6) 2024, the patient was taken to the operating room.Intra-operatively, the valve had fibrous-calcific deterioration with significant adhesions and tissue-in-growth between the trifecta gt valve and the aortic wall.Due to the adhesions and tissue-in-growth the trifecta gt valve had to be broken into multiple smaller pieces in order to remove it from the aortic wall.The surgical procedure was complex and took more than 6 hours and ultimately the patient could not be separated from cardiopulmonary bypass and died during surgery on (b)(6) 2024.

Manufacturer Narrative

It was reported that the patient presented with structural valve deterioration (svd) and evidence of aortic valve regurgitation with at least one leaflet collapsed.The patient was taken to the operating room for aortic valve replacement.It was reported intra-operatively the valve had fibrous-calcific deterioration with significant adhesions and tissue-in-growth between the trifecta gt valve and the aortic wall.Due to the adhesions and tissue-in-growth the trifecta gt valve had to be broken into multiple smaller pieces in order to remove it from the aortic wall.Field indicated that the surgical procedure was complex and took more than six hours and ultimately the patient could not be separated from cardiopulmonary bypass and the patient expired during surgery.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.A variety of factors may contribute to svd, including patient, biological, and implant related factors: no implant related factors could be confirmed from the information received from the field as information related to implant procedure was not provided.Based on information received the valve had fibrous-calcific deterioration with significant adhesions and tissue-in-growth, which may have contributed to the reported svd, however could not be confirmed as the valve was not returned for histopathological examination.The cause of patient death could not be conclusively determined, however based on medical review the patient death could possibly be related to difficulty explanting the trifecta gt valve in the presence of adhesions to the aortic wall which most likely prolonged the implant procedure and required repair of the aorta.The date of procedure was estimated as (b)(6) 2020 as it was reported that the device was implanted on an unknown date in the year 2020.

• 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: 18739672
• MDR Text Key: 335763245
• Report Number: 2135147-2024-00744
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TFGT-21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Death
• Patient Age: 76 YR
• Patient Sex: Female