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

Model Number	TFGT-23A
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); High Blood Pressure/ Hypertension (1908); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	11/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that patient presented with hypertension and severe aortic insufficiency after five years of trifecta valve implant.Based on the information received, the reported stenosis is consistent with structural valve deterioration (svd), specifically fibro-calcific svd (fcsvd), which is a well-known complication of tissue heart valve replacement surgery.A variety of factors may contribute to svd, including patient, biological, and implant related factors.Biological factors which can result in stenosis such as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.), immobilizing thrombus, or pannus formation reducing the valve diameter also could not be confirmed as the valve was not returned for histopathological examination.Based on review of the information available, the aorta was cannulated with no calcifications on palpation.The left ventricle function was normal.The trifecta valve with significant pannus formation, rigid nc leaflet and tear at post.Normal lvef following cpb run with no evidence of paravalvular leak.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 information received, the pannus formation and leaflet tear may have contributed to the reported regurgitation, however this could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2018, a 23mm trifecta valve was implanted for aortic stenosis.On (b)(6) 2023, patient presented with hypertension (htn) and severe aortic insufficiency.A redo-aortic valve replacement was performed and the valve was replaced with a 23mm non-abbott valve.The patient was reported stable.
Event or Problem Description
It was reported that on 08 november 2018, a 23mm trifecta valve was implanted for aortic stenosis.On 04 october 2023, patient presented with hypertension (htn) and severe aortic insufficiency.On (b)(6) 2023, a redo-aortic valve replacement was performed and the valve was replaced with a 23mm non-abbott valve.The patient status is unknown.No further information has become available.
Additional Manufacturer Narrative
It was reported that patient presented with hypertension and severe aortic insufficiency after five years of trifecta valve implant.A redo-aortic valve replacement was performed and the valve was replaced with a 23 mm non-abbott valve.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The surgical intervention is a result of valve explant.The device history record was also 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 respect to labeling design or manufacturing of the device.This individual case was received by the manufacturer as part of a bulk report and is being submitted as a separate medical device report (mdr) specific to the identified device and patient.

• 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: 20487318
• Report Number: 2135147-2024-05193
• Device Sequence Number: 11642548
• Product Code: LWR
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 06/25/2026

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: 01/15/2022
• Device Model Number: TFGT-23A
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 6304410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male