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

Model Number	TF-27A
Medical Device Problem Codes	Calcified (1077); Incomplete Coaptation (2507); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Atrial Fibrillation (1729); Dyspnea (1816); Fatigue (1849); Hemothorax (1896); Heart Block (4444)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2019, a 27mm trifecta valve was implanted during an aortic valve replacement.The patient had a history of a bicuspid aortic valve.In (b)(6) 2024, the patient began complaining of shortness of breath and fatigue.On (b)(6) 2024, the patient was informed that the valve was failing and needed to be replaced due to aortic stenosis and calcification.On (b)(6) 2024, the valve was explanted and replaced with a non-abbott mechanical heart valve.The trifecta valve was noted to be calcified.The patient status was stable and discharged.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that the patient began complaining of shortness of breath and fatigue after 5 years of trifecta valve implant.Also reported that explanted and replaced due to aortic stenosis and calcification and was noted to be be calcified upon explant.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 from the field as 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 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 cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that on (b)(6) 2019, a 27mm trifecta valve was implanted during an aortic valve replacement.The patient had a history of a bicuspid aortic valve.In (b)(6) 2024, the patient began complaining of shortness of breath and fatigue.On (b)(6) 2024, the patient was informed that the valve was failing and needed to be replaced due to aortic stenosis and calcification.On (b)(6) 2024, the valve was explanted and replaced with a non-abbott mechanical heart valve.The trifecta valve was noted to be calcified.The patient status was stable and discharged.
Additional Manufacturer Narrative
It was reported that the patient developed hemothorax and atrial fibrillation next day of trifecta valve implant.After approximately four years of implant, the patient began complaining of shortness of breath and fatigue.Also reported that the trifecta valve was explanted and replaced with non-abbott valve due to aortic stenosis and calcification.Reportedly, upon explant of trifecta valve operative findings identified two of the three leaflets were fairly immobile.The patient's post-operative course was complicated by a third-degree heart block and was resolved after discontinuing beta-blockers.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the explanted device was not returned for analysis.The reported calcification may have contributed to stenosis.The cause of the reported patient effects of hemothorax and atrial fibrillation could not be conclusively determined.The cause of the reported patient effects of dyspnea and fatigue after four years of implant could not be conclusively determined.It is possible that patient condition (stenosis) could have contributed to this event.However, this cannot be confirmed.The reported unexpected medical intervention and surgical intervention were the results of case-specific circumstances, as thoracostomy was performed for hemothorax treatment medication (amiodarone) was administered for atrial fibrillation, the valve was surgically explanted.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.
Event or Problem Description
It was reported that on (b)(6) 2019, a 27mm trifecta valve was implanted for an aortic valve replacement (avr) procedure in a patient with a native bicuspid aortic valve.It was then reported on (b)(6) 2019, the patient developed hemothorax and atrial fibrillation.A decision was made to place a right ultrasound guided thoracostomy tube for hemothorax treatment.Atrial fibrillation which was chemically converted with intravenous amiodarone.The patient was discharged on (b)(6) 2019.Approximately four years post-procedure, the patient began complaints of shortness of breath and fatigue.On (b)(6) 2024, during a routine five-year echocardiogram follow-up, the patient was informed that the valve was failing and needed to be replaced due to aortic stenosis and calcification, with fusion along the commissures.The patient also complained of occasional lightheadedness in the mornings.On (b)(6) 2024, right heart catheterization noted normal coronary arteries, mild myocardial bridging, mildly elevated pulmonary pressures, mildly elevated cardiac output and known severe aortic valve stenosis.A decision was made to perform redo-avr on (b)(6) 2024, the valve was surgically explanted and replaced with a 23mm non-abbott mechanical heart valve.After removal from patient anatomy, operative findings identified two of the three leaflets were fairly immobile on the 27mm trifecta valve.The patient's post-operative course was complicated by a third-degree heart block and was resolved after discontinuing beta-blockers.The patient status was reported stable and in cardiac rehab.

• Brand Name: TRIFECTA¿
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20429135
• Report Number: 2135147-2024-05027
• Device Sequence Number: 12871952
• Product Code: LWR
• UDI-Device Identifier: 05414734052054
• UDI-Public: (01)05414734052054(17)180316
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup
• Report Date (Section B): 06/20/2025

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: 03/16/2018
• Device Model Number: TF-27A
• Device Catalogue Number: TF-27A
• Device Lot Number: 5741370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/30/2024; 06/06/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/14/2024; 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2016
• 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; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male