MAUDE Adverse Event Report: Abbott Medical Trifecta¿; Heart-Valve, Non-Allograft Tissue

Model Number	TF-23A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2017, a 23mm sjm trifecta valve was implanted for a aortic valve replacement procedure.On (b)(6) 2025, the patient required premature replacement.While attempting to close chest, the patient developed ventricular tachycardia and ventricular fibrillation and ultimately required placement of veno-arterial extracorporeal membrane oxygenation (va-ecmo).The patient's chest remained open until (b)(6)2025.An automated implantable cardioverter-defibrillator was placed on (b)(6) 2025 prior to discharge the same day.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.

• 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 ; +1(651)756-5400
• MDR Report Key: 50896836
• Report Number: 2135147-2026-06489
• Device Sequence Number: 16142733
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: (01)05414734052030(17)180320
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 03/20/2018
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Device Lot Number: BR00006945
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown