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

Catalog Number	TF-25A
Medical Device Problem Codes	Degraded (1153); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The article, "case series of early structural valve deterioration of trifecta bioprosthesis - new zealand experience", was reviewed.The article presented a case study of an 79-year-old male with hypertension, stage 4 chronic kidney disease, history of smoking, diabetes, and dyslipidemia.It was reported that on an unknown date in february 2017, a 25mm trifecta valve was implanted in the patient with a concomitant coronary aortic bypass graft procedure.On an unknown date, the patient was diagnosed with asymptomatic murmur due to transesophageal echocardiography (tee) showing two regurgitant jets, one from the non-coronary and left coronary cusp and another from the non-coronary and right coronary cusp base.It was later reported on an unknown date the patient presented with heart failure.A decision was made to perform a transcatheter valve-in-valve procedure and implant a 26mm non-abbott valve on an unknown date 20 months post initial procedure.The article concluded the trifecta valve has an acceptable safety profile and offers good hemodynamics due to the externally mounted leaflets.However, their experience of early svd and failure is concerning for valve durability.Further comparison to other bioprosthetic valves and longer term follow-up are required to characterize the mechanism of failures.[(b)(6)].
Additional Manufacturer Narrative
Literature article: case series of early structural valve deterioration of trifecta bioprosthesis - new zealand experience.As reported in a research article, aortic valve insufficiency/ regurgitation, heart failure, and central regurgitation were reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review, and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Using the device in a position not recommended in the instructions for use could have contributed to the reported event.

• 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: 17712249
• Report Number: 2135147-2023-03907
• Device Sequence Number: 6731116
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TF-25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 09/08/2023
• 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; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male