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

Model Number	TF-A
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported in a research article, a vegetation and endocarditis was found on a valve that had been implanted for five years.A more comprehensive assessment, including histopathological 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 event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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, amiens-picardie university hospital, 1 rond-point du professeur christian cabrol, 80054 amiens, france, with email address of : richez.Ophelie@chu-amiens.Fr].It was reported that in (b)(6) 2013, a 25mm trifecta valve was implanted in a patient with a past medical history of aortic insufficiency.It was reported that in (b)(6) 2018, the patient had mitro-aortic endocarditis, eccentric receding bioprosthesis plunging towards the large mitral valve.The was also lower right sigmoid thickening which remains mobile, vegetation > 10mm.No abscess or paraprosthetic leak.7mm vibrate image on the auricular side of the small mitral valve with im grade 1.Absence of damage to the other valves.On (b)(6) 2018, a surgical intervention was completed with a new trifecta 25mm valve.Post procedure of the second valve in (b)(6) 2020, there was dilation of the ascending aorta measured at 4 cm greater, poly-valvular heart disease with a significant mitral leak and severe aortic insufficiency and ac / af.Requiring replacement with a 21mmregent heart valve w/flex cuff.Patient status is unknown, no additional information was provided.

• 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: 16781617
• Report Number: 2135147-2023-01745
• Device Sequence Number: 20510446
• 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: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2023

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-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: 03/29/2023
• Initial Report FDA Received Date: 04/20/2023
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown