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

Model Number	TF-A
Medical Device Problem Codes	Perivalvular Leak (1457); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was report that in (b)(6) 2016, a 25mm trifecta valve was implanted during an aortic valve replacement.On (b)(6) 2021, echocardiography showed aortic regurgitation without stenosis.The average lv-aortic gradient was 8 mmhg.The maximum lv-aortic gradient was 16 mmhg.The diameter of the flush chamber was 25 mm.The sub-aortic velocity time integral (vti) was 20 cm.The aortic vti was 42 cm.The aortic vmax was 201 cm/s.Minimal aortic insufficiency, grade 1 of 4, was noted.Moderate perivalvular aortic leakage of grade 2 was noted.The valve was not replaced.The patient status was unknown.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
The abstract article, "trifecta bioprostheses: evaluation of the safety based on the study of degenerations according to the varc-3 classification", was reviewed.The research article is a retrospective single center experience to evaluate the intrinsic imputability of trifecta for dysfunction according to the varc-3 classification in patients implanted and to reassess their referencing in our center.Trifecta valve was the device associated with this study.The article concluded, the classification of failures according to varc-3 indicated the intrinsic imputability of the trifecta¿ bioprostheses regarding to the number of svd-type dysfunctions.Although this study has limitations, it shows the understatement of medical-devices-vigilance cases by the medical staff.[the primary author of this article is richez, ophelie, (b)(6) hospital, (b)(6).It was report that in (b)(6) 2016, a 25mm trifecta valve was implanted during an aortic valve replacement.On (b)(6) 2021, echocardiography showed aortic regurgitation without stenosis.The average lv-aortic gradient was 8 mmhg.The maximum lv-aortic gradient was 16 mmhg.The diameter of the flush chamber was 25 mm.The sub-aortic velocity time integral (vti) was 20 cm.The aortic vti was 42 cm.The aortic vmax was 201 cm/s.Minimal aortic insufficiency, grade 1 of 4, was noted.Moderate perivalvular aortic leakage of grade 2 was noted.The valve was not replaced.The patient status was unknown.No additional information was provided.
Additional Manufacturer Narrative
As reported in a research article, regurgitation was noted almost six years after the valve was implanted.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 pathological examination of the valve tissue, could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 16716102
• Report Number: 2135147-2023-01525
• Device Sequence Number: 7274830
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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: 08/08/2017
• Device Model Number: TF-A
• Device Catalogue Number: TF-25A
• Device Lot Number: 5208909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2015
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Unknown