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

Catalog Number	TF-21A
Medical Device Problem Codes	Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Shock (2072); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	03/17/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2014, a 21mm trifecta valve was implanted during an aortic valve replacement.In (b)(6) 2019, the patient presented to the hospital with shortness of breath.An echocardiogram was performed, which showed worsening aortic stenosis.During the pre-surgical workup, it was determined that the patient had a low left main coronary ostium and a 6x4x5cm tissue mass in the right cardiophrenic angle continuous with the pericardium.On (b)(6) 2019, the patient was admitted to the hospital for evaluation of transcatheter aortic valve replacement vs.Surgical aortic valve replacement.On (b)(6) 2019, the patient had a heart catheterization performed, which demonstrated mild bilateral enlargement, severe aortic stenosis, moderate aortic regurgitation, moderate mitral regurgitation, dilated mildly hypokinetic left ventricle, and a mal-positioned prosthetic aortic valve.The patient was volume overloaded with a wedge pressure of 35mmhg.The patient was admitted to the cardiovascular intensive care unit (cvicu) with congestive heart failure.On (b)(6) 2019, the surgery service noted that the patient needed a redo surgical prosthetic valve.On (b)(6) 2019, a repeat echocardiogram showed that the patient's ejection fraction had dropped to 15% and that mitral regurgitation had increased.The patient was in shock in the setting of worsening left ventricular systolic function and multivalvular disease.On (b)(6) 2019, the patient passed away from cardiogenic shock due to worsening valvular heart disease.
Additional Manufacturer Narrative
An event of aortic valve stenosis, aortic valve regurgitation, shock, shortness of breath, congestive heart failure, hospitalization, and death was reported.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 reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the available information and medical review, the cause of the reported death appears to be related to heart failure.The cause of cardiogenic shock appears to be related to fibrous-calcific svd.However, a cause of heart failure, fibrous-calcific svd, and aortic valve regurgitation and stenosis could not be conclusively determined.The reported hospitalization was a result of case-specific circumstance as the patient was admitted for evaluation.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: TRIFECTA¿
• 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: 20759472
• Report Number: 2135147-2024-05942
• Device Sequence Number: 21152911
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: (01)05414734052023(17)160405(10)4579662
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 01/17/2025

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: 04/05/2016
• Device Catalogue Number: TF-21A
• Device Lot Number: 4579662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2014
• 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: Death
• Patient Age: 69 YR
• Patient Sex: Female