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

Model Number	TF-21A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/22/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that a 21a mm trifecta valve was implanted on (b)(6) 2021.It was reported that on an unknown date the patient passed away.The cause of death is unknown.No further information has become available.
Additional Manufacturer Narrative
B2 - date of death is estimated.A surgical explant of the device and the patient¿s death were reported, with the unknown cause.A more comprehensive assessment could not be performed as limited information was available, and 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 information available, the cause of reported patient's death cannot be conclusively determined.There is no indication of a product quality issue related to the device¿s labeling, design, or manufacturing.Based on medical review: "due to the limited clinical and case-specific information provided for these fatality cases, a medical review cannot be completed at this time.The available details are insufficient to support an assessment.If additional relevant information becomes available, a medical review will be conducted." 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 LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25537810
• Report Number: 2135147-2026-04178
• Device Sequence Number: 9616573
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: (01)05414734052023(17)180609
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2018
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: BR00008023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2016
• 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: Death
• Patient Age: 74 YR
• Patient Sex: Unknown