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

Model Number	TF-21A
Medical Device Problem Codes	Calcified (1077); Patient-Device Incompatibility (2682); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Syncope/Fainting (4411); Movement Disorder (4412)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2016, a 21mm trifecta valve was successfully implanted in a patient.On (b)(6) 2025, it was noted via echocardiogram that the patient had increased aortic valve gradients and syncope.The patient also had mitral valve stenosis of a 27mm non-abbott device.The patient also exhibited symptoms of shortness of breath, and dizziness.There was no aortic regurgitation present or chronic renal insufficiency.On (b)(6) 2025, the decision was made to explant the 21mm trifecta valve and replace it with a 21mm epic plus supra valve.The valve was successfully explanted and replaced without handling the valve with any unprotected forceps or sharp instruments.The explanted 21mm trifecta valve had no tear observed in the leaflets or suture cuff.However, the valve was found to have fibrosis, pannus, and calcification.There was no noted interaction between any stent post and patient anatomy.The patient does not have other comorbidities that may impact calcium metabolism and does not take calcium supplements.The patient was stable at the time of report.
Additional Manufacturer Narrative
An event of shortness of breath, aortic stenosis, dizziness and valve explanted was reported.The valve was replaced with non-abbott valve.The device was returned to abbott and the investigation found that biological material and blood/body fluids were present throughout the valve.The leaflets had limited mobility when manually manipulated.It was indicated that the explanted trifecta valve had no tear observed in the leaflets.However, the valve was found to have fibrosis, pannus, and calcification.There was no noted interaction between any stent post and patient anatomy.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the reported event could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the device had to be explanted.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Per the information available abbott cannot further speculate on why the reported event occurred.
Additional Manufacturer Narrative
Subsequent to the previously filed report, the investigation summary was updated: an event of shortness of breath, aortic stenosis, dizziness and valve explanted was reported.Also reported that valve was replaced with non-abbott valve.The device was returned to abbott and the investigation found that biological material and blood/body fluids were present throughout the valve.The leaflets had limited mobility when manually manipulated.The valve was found to have fibrosis, pannus, and calcification.There was no noted interaction between any stent post and patient anatomy.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the reported event could not be conclusively determined.The cause of the reported stenosis may be related to the pannus and calcification formation.However, the cause of the pannus and calcification formation could not be conclusively determined.The reported dyspnea and may be a cascading effect of aortic valve stenosis.The reported surgical intervention was a result of case-specific circumstances as the device had to be explanted.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: 21774056
• Report Number: 2135147-2025-01737
• Device Sequence Number: 9821886
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: (01)05414734052023(17)170602
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2017
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 5135772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 05/13/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/02/2025; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2015
• 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: 76 YR
• Patient Sex: Female