MAUDE Adverse Event Report: ABBOTT MEDICAL Trifecta¿ GT Valve; Heart-Valve, Non-Allograft Tissue

Model Number	TFGT-23A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Hypoxia (1918); Shock (2072); Thrombocytopenia (4431); Heart Failure/Congestive Heart Failure (4446)
Date of Event	12/26/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
An event of structural valve deterioration and device stenosis was reported after six years of implant.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 available, the cause of reported patient effects could not be conclusively determined.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The reported hospitalization and surgical intervention were a result of case-specific circumstances as surgical removal of device was performed and the patient required prolonged hospitalization.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 gt heart valve was implanted for surgical aortic valve replacement (savr).Approximately five years post-procedure in 2023, the patient developed rapid and severe valve dysfunction of the trifecta gt device.In (b)(6) 2023, patient was hospitalized for acute congestive heart failure with severe aortic stenosis.A decision was made to perform redo-savr on (b)(6) 2023 with a 23mm epic plus supra aortic valve.The patient's post-operative course was complicated by cardiogenic shock requiring intravenous aortic balloon pump support, progressive hypoxia, multiorgan failure, and severe thrombocytopenia.Comfort measures were implemented due to critically poor prognosis and patient passed away on (b)(6) 2023.The death certificate identified prosthetic aortic valve stenosis as part of the causal chain leading to death.
Additional 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.
Additional Manufacturer Narrative
An event of structural valve deterioration and device stenosis was reported after six years of implant.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 available, the cause of reported patient effects could not be conclusively determined.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The reported hospitalization and surgical intervention were a result of case-specific circumstances as surgical removal of device was performed and the patient required prolonged hospitalization.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.\ \ based on medical review: \"procedure related.Indirectly related to the deterioration of the device.Possibly related to the patient's underlying co-morbidities.\".
Event or Problem Description
It was reported that on (b)(6) 2018, a 23mm trifecta gt heart valve was implanted for surgical aortic valve replacement (savr).Approximately five years post-procedure in 2023, the patient developed rapid and severe valve dysfunction of the trifecta gt device.In (b)(6) 2023, patient was hospitalized for acute congestive heart failure with severe aortic stenosis.A decision was made to perform redo-savr on (b)(6) 2023 with a 23mm epic plus supra aortic valve.The patient's post-operative course was complicated by cardiogenic shock requiring intravenous aortic balloon pump support, progressive hypoxia, multiorgan failure, and severe thrombocytopenia.Comfort measures were implemented due to critically poor prognosis and patient passed away on (b)(6) 2023.The death certificate identified prosthetic aortic valve stenosis as part of the causal chain leading to death.
Event or Problem Description
It was reported that on (b)(6) 2018, a 23mm trifecta gt heart valve was implanted for surgical aortic valve replacement (savr).Approximately five years post-procedure in 2023, the patient developed rapid and severe valve dysfunction of the trifecta gt device.In (b)(6) 2023, patient was hospitalized for acute congestive heart failure with severe aortic stenosis.A decision was made to perform redo-savr on (b)(6) 2023 with a 23mm epic plus supra aortic valve.The patient's post-operative course was complicated by cardiogenic shock requiring intravenous aortic balloon pump support, progressive hypoxia, multiorgan failure, and severe thrombocytopenia.Comfort measures were implemented due to critically poor prognosis and patient passed away on (b)(6) 2023.The death certificate identified prosthetic aortic valve stenosis as part of the causal chain leading to death.

• 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 Ltda. Reg#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 25382539
• Report Number: 2135147-2026-03749
• Device Sequence Number: 9463060
• Product Code: LWR
• UDI-Device Identifier: 05415067018229
• UDI-Public: (01)05415067018229(17)211023
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/29/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2021
• Device Model Number: TFGT-23A
• Device Catalogue Number: TFGT-23A
• Device Lot Number: BR00014642
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2017
• 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: Required Intervention; Other; Death; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female