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

Catalog Number	TF-23A
Medical Device Problem Codes	Perivalvular Leak (1457); Material Separation (1562); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Atrial Fibrillation (1729); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2015, a 23mm trifecta valve was successfully implanted in a patient.On an unknown date it was noted that the valve was stenosed.On (b)(6) 2024, the decision was made to perform a valve-in-valve procedure using a 25mm portico ng/navitor valve.On (b)(6) 2024, it was noted that there was paravalvular leakage of the 23mm trifecta valve.The decision was made to stop the patient's bisoprolol medication.On (b)(6) 2024, the patient underwent an unknown perivalvular leak (pvl) repair procedure.It's noted that one day after the pvl repair procedure, the patient developed a 5 second pause with atrial fibrillation.The patient discharged at the time of report.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
H6 medical device problem code 4066 (device stenosis) was removed.It was reported that the patient had perivalvular leak, severe aortic regurgitation and exertional dyspnea after 8 years of trifecta valve implant.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 reported event is consistent with structural valve deterioration (svd), specifically fibro-calcific svd (fcsvd), which is a well-known complication of tissue heart valve replacement surgery.A variety of factors may contribute to svd, including patient, biological, and implant related factors.No implant related factors could be confirmed from the information received from the field as information related to implant procedure was not provided.Biological factors which can result in stenosis such as calcification (from patient conditions predisposing to elevated calcium like renal disease etc.), immobilizing thrombus, or pannus formation reducing the valve diameter also could not be confirmed as the valve was not returned for histopathological examination.The exact cause of the reported incident could not be conclusively determined.The reported surgical intervention was a result of valve-in-valve implant.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
Subsequent to the previously filed reported, additional information was received that there was no stenosis of the 23mm trifecta valve.However, it was noted on an unknown date, that the patient was found to have severe aortic regurgitation and exertional dyspnea.The grade of the perivalvular leak after the valve-in-valve procedure was moderate with a mean aortic gradient of 21 mmhg.The cause of the perivalvular leak (pvl) is attributed to suture dehiscence.A 12x9mm amplatzer vascular plug 2 was implanted to treat the pvl.

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20271422
• Report Number: 2135147-2024-04660
• Device Sequence Number: 11611456
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: (01)05414734052030(17)160928(10)4839768
• 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: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: 09/28/2016
• Device Catalogue Number: TF-23A
• Device Lot Number: 4839768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2014
• 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; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 88 KG