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

Model Number	TF-25A
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Syncope/Fainting (4411); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2014, a 25mm trifecta valve was implanted in the patient.On (b)(6) 2024, patient presented with dyspnea and syncope.The physician confirmed the aortic valve prosthesis had exuberant calcification and there was both stenosis and regurgitation.The valve was explanted and a new 21mm non-abbott valve was implanted.The patient was reported stable.
Additional Manufacturer Narrative
It was reported dyspnea and syncope around 10 years of trifecta valve implant.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.However, 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: no implant related factors could be confirmed from the information received.Information related to implant procedure was not provided.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.The exact cause of the 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.
Event or Problem Description
It was reported that on (b)(6) 2014, a 25mm trifecta valve was implanted in the patient.On (b)(6) 2024, patient presented with dyspnea and syncope.The physician confirmed the aortic valve prosthesis had exuberant calcification and there was both stenosis and regurgitation.On (b)(6) 2020, the valve was explanted and a new 21mm non-abbott valve was implanted.The patient was reported stable.The patient status is unknown.No further information has become available.
Additional Manufacturer Narrative
An event of dyspnea and syncope was reported.Additionally, it was also reported that aortic valve prosthesis had exuberant calcification and there was both stenosis and regurgitation.The trifecta valve was explanted after 6 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 available information, the cause of the reported incident and patient effects could not be conclusively determined.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¿
• 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: 20487244
• Report Number: 2135147-2024-05189
• Device Sequence Number: 4174708
• Product Code: LWR
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• 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: 10/14/2015
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 4325749
• 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): Yes
• Date Device Manufactured: 10/15/2013
• 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; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male