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

Catalog Number	TFGT-25A
Medical Device Problem Codes	Degraded (1153); Device Stenosis (4066)
Health Effect - Clinical Codes	Angina (1710); Aortic Valve Stenosis (1717); Dyspnea (1816); Fatigue (1849)
Date of Event	12/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch report #: mw5150926 investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Medwatch report #: mw5150926 received regarding a 25mm trifecta bioprosthetic aortic valve experienced episodes of dizziness, chest pain, arm pain, shortness of breath, lethargic, unable to lie down.It passed.Then, happened again a few days later and was taken to er.Sent home the same day.Worsening episodes to include belching, and not hungry.Returned to hospital (b)(6) 2024.Diagnosed (b) (6) 2024 with severe prosthesis stenosis of a st.Jude trifecta bioprosthetic aortic valve.Patient was transferred to (b)(6) and is awaiting possible tavr procedure currently.It was reported that on 26 august 2016, a 25mm trifecta valve was implanted.On (b)(6) 2023, the patient experienced episodes of dizziness, angina, arm pain, dyspnea, lethargy, unable to lie down.The symptoms eventually passed but then came back a few days later so the patient was taken to the emergency room.The patient returned home the same day.Symptoms began to then include belching and reduced appetite.On (b)(6) 2024, the patient was hospitalized and diagnosed with severe aortic stenosis.Patient was transferred and is awaiting possible intervention.
Additional Manufacturer Narrative
An event of severe aortic stenosis 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.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 received information, the cause of reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Attachment medwatch report #: mw5150926.

• 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: 18874523
• Report Number: 2135147-2024-01056
• Device Sequence Number: 9136214
• Product Code: LWR
• UDI-Device Identifier: 05415067018236
• UDI-Public: (01)05415067018236(17)180209(10)5403737
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: 02/09/2018
• Device Catalogue Number: TFGT-25A
• Device Lot Number: 5403737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2016
• 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
• Patient Sex: Unknown