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

Catalog Number	TF-27A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.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 27mm trifecta valve was implanted during an aortic valve replacement.On a later date, the patient presented with severe shortness of breath to the emergency department.The patient was admitted to the hospital.On (b)(6) 2023, the valve was urgently explanted and replaced with an unknown valve.The explanted valve had a tear at one of the commissures.The patient status was unknown.
Additional Manufacturer Narrative
Explant of the trifecta valve due to a tear in the leaflet was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.The cause of the leaflet tear could not be conclusively determined.

• Brand Name: SJM TRIFECTA VALVE
• 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: 17612575
• Report Number: 2135147-2023-03713
• Device Sequence Number: 15333955
• Product Code: LWR
• UDI-Device Identifier: 05414734052054
• UDI-Public: 05414734052054
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 10/23/2023

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: 07/04/2017
• Device Catalogue Number: TF-27A
• Device Lot Number: BR00003735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2015
• 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 Sex: Male