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

Model Number TF-A

Device Problems Calcified (1077); Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Cardiac Arrest (1762); Dyspnea (1816); Pericardial Effusion (3271)

Event Date 10/30/2020

Event Type  Death  

Manufacturer Narrative

As reported in a research article about 6 years after the valve was implanted stenosis and valve degeneration were noted.It was reported that the patient died about 6 months after following hospitalization and cardio-respiratory arrest in the context of tight calcified aortic stenosis.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 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 incident could not be conclusively determined, however the reported calcification on the valve could have contributed to the reported stenosis.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event 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 2014, a 23mm trifecta valve was implanted during an aortic valve replacement.A post-operative ultrasound was performed, which showed left ventricular hypertrophy, normal lv systolic function.The ejection fraction was 55-60%.The valve was working as intended without any leak.A 5-6mm, non-compressive pericardial effusion was noted.On 10 january 2020, the patient experienced an increase in exertional dyspnea, and the aortic valve stenosis and degeneration were noted.In may 2020, the average aortic gradient was 61mmhg.The left ventricular ejection fraction was 68%.On 26 october 2020, the patient died following hospitalization and cardio-respiratory arrest in the context of tight calcified aortic stenosis.No additional information was provided.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16817212
• MDR Text Key: 314030500
• Report Number: 2135147-2023-01835
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2015
• Device Model Number: TF-A
• Device Catalogue Number: TF-23A
• Device Lot Number: 4445021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR