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

Model Number TF-A

Device Problems Patient-Device Incompatibility (2682); Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Endocarditis (1834)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, endocarditis, stenosis, and thickening of the valve leaflets was noted 5 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 reported leaflet thickening could have contributed to the stenosis reported, however the cause of the leaflet thickening could not be conclusively determined.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 (b)(6) 2015, a 23mm trifecta valve was successfully implanted in a patient with calcified aortic stenosis.In (b)(6) 2020, it was reported that there was endocarditis on bioprosthesis.The patient was on amoxicillin 2 g x 4 per day and associated with rifampicin600 mg x 2 per day for a total duration 6 weeks, i.E.Until (b)(6) 2020.On (b)(6) 2020, there was no valve disinsertion, but thickened valve cusps with a surface area of 1.3cm² (3d planimetry) and vmax 3 m/s on average was observed.On (b)(6) 2020, echocardiography showed a moderately stenotic aortic valve (mean gradient 23 mm hg, maximum speed 3 m/sec) that was non-leaking.Transthoracic echocardiography showed posterior pseudo aneurysm without visualized fistulation.Mitral insufficiency was stable; moderate grade ii by restriction of the posterior leaflet.No increase in left ventricular filling pressures.Left ventricle slightly dilated (57 mm in tele diastole, 42 mm in tele systole).Fraction satisfactory left ventricle ejection, at 54% in biplane at 50% visually.Undulated straight cavities.No indirect sign of high blood pressure.No pericardial effusion.The valve remains implanted.The patient status is unknown.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 #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: 16780067
• MDR Text Key: 313686069
• Report Number: 2135147-2023-01736
• 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: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2017
• Device Model Number: TF-A
• Device Catalogue Number: TF-23A
• Device Lot Number: 5011130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2015
• 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): Required Intervention
• Patient Age: 72 YR