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

Model Number	TF-A
Medical Device Problem Codes	Calcified (1077); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported in a research article, about six years after the valve was implanted, stenosis, regurgitation and calcification were noted on the valve and the valve was replaced.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 reported calcifications could have contributed to the stenosis and regurgitation reported however as the presence of the calcifications could not be confirmed 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 on 30 may 2013, a 25mm trifecta valve was successfully implanted due to calcified aortic stenosis in a patient.On 4 february 2019, it was observed that the patient had predominantly left-sided cardiac decompensation caused by degeneration of trifecta valve.Left ventricular dysfunction was measured 30-35%.On 9 may 2019, it was observed that the patient had a very calcified aortic valve, and the valve opening was reduced.Aortic insufficiency was noted in a small leak though the center of the valve.The maximum velocity was measured at 4.2m/s and the gradient was measured at 43mmhg.Severe stenosis was noted due to valve degeneration.Minimal leakage was observed and the mitral valve was also observed to be calcified.On 23 may 2019, percutaneous aortic valve replacement was performed using a 29mm non-abbott valve.A minimal residual aortic leak was observed post valve replacement.It was noted that the patient had repeated acute pulmonary edemas and multiple hospitalizations due to cardiac decompensation.

• 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: 16778389
• Report Number: 2135147-2023-01731
• Device Sequence Number: 6858397
• 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: 2013
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Initial Reporter Occupation: Other
• 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 Expiration Date: 12/04/2016
• Device Model Number: TF-A
• Device Catalogue Number: TF-25A
• Device Lot Number: 4921618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2014
• 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
• Patient Age: 69 YR
• Patient Sex: Unknown