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

Model Number	TF-A
Medical Device Problem Codes	Degraded (1153); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Angina (1710); Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2017, a 19mm trifecta valve was successfully implanted.Prior to implant, the annulus size was measured to be 19mm.On (b)(6) 2020, the patient stated that they began to experience chest pain.A transthoracic echocardiogram and angiogram were performed, and the patient was advised for aortic valve replacement due to aortic stenosis, structural valve deterioration, atrial regurgitation (ar).The patient was reported as stable and was planning for valve replacement in the future.The valve was not surgically replaced at the time of last report.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of aortic stenosis, structural valve deterioration, and atrial regurgitation was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Naa.
Additional Manufacturer Narrative
An event of aortic stenosis, structural valve deterioration, and atrial regurgitation was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident 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 #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: 17270782
• Report Number: 2135147-2023-02922
• Device Sequence Number: 19724471
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2023

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 Model Number: TF-A
• Device Catalogue Number: TF-19A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 07/16/2023; 09/26/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/07/2023; 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown