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 Problem Aortic Valve Stenosis (1717)

Event Date 12/01/2018

Event Type  Death  

Manufacturer Narrative

Literature attachment: trifecta¿ bioprostheses : evaluation of the safety based on the study of degenerations according to the varc-3 classification.As reported in a research article, 6 years after the valve was implanted calcification and stenosis was noted, and about seven years after the valve was implanted a valve-in-valve was performed.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 calcifications reported could have contributed to the reported stenosis, however as the valve was not received for examination this could not be confirmed and the cause of the reported event could not be conclusively determined.

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 an unknown day in september of 2012, a 23mm trifecta valve was successfully implanted in a 69 year old patient with endocarditis of their native aortic valve.It was noted that on an unknown day in december of 2018, it as noted that the cusps of the 23mm trifecta valve had become calcified and aortic valve stenosis had occurred.There was no leak detected, but stenosed degeneracy requiring a closer patient follow up.On an unknown in april of 2019, the same calcification of the valve cusps and stenosis was noted.The flow velocity was 3.9m/sec and the left ventricular/aortic gradient was 39mmhg.The area of patient's aortic valve was 0.8cm² and again there was no leak detected.The patient also had the following mitral valve details, mitral plasty was not stenosed, left atrial/left ventricular gradient of 4mmhg, known significant residual leak, with a regurgitative ejection fraction area estimated at 34mm², volume 38ml.The left ventricle was slightly dilated with paradoxal septum, and ejection fraction at 51-60%.The following tricuspid valve information was also provided, moderate leak, systolic pulmonary artery pressure at 33mmhg.On an unknown day in june of 2019, a valve-in-valve procedure was performed using r26 non-abbott device.There was no residual aortic leak noted post intervention.On an unknown day in july 2021, the patient died due to septic shock of unknown origin.

• 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 #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: 16854514
• MDR Text Key: 314394011
• Report Number: 2135147-2023-01901
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2014
• Device Model Number: TF-A
• Device Catalogue Number: TF-23A
• Device Lot Number: 13831970
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2012
• 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: 69 YR