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

Model Number TF-A

Device Problems Degraded (1153); Patient-Device Incompatibility (2682); Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Endocarditis (1834); Nausea (1970)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6)2015, a 23mm trifecta valve was successfully implanted in a 66 year old patient due to syncopal calcified aortic stenosis.On (b)(6) 2015, a bioprothesis was seen in the aortic position with minimal leakage observed.The average gradient was measured to be 10mm and no stenosis was noted.The valve was non-dilated, non-hypertrophied left ventricle, there was normal left ventricular systolic function, the ejection fraction was 55-60%, and the straight cavities were un-dilated.There were no abnormal segment kinetics, no hypertension, and no pericardial effusion noted.The patient was hospitalized in the neurology ward on (b)(6)2019 to (b)(6) 2019 for management of an ischemic stroke.An echography was performed on (b)(6) 2019, and endocarditis was seen on the aortic bioprosthesis, with the appearance of a potential non-circulating abscess of the posterior annulus, extending towards the mitral-aortic trigone.Of the two vegetations, one measured 11mm in length.No fistula or periprosthetic leak was observed.The patient tested positive three times for staphylococcus and began antibiotic (atb) therapy immediately.The patient was transferred to the cardiology unit.The patient had symptoms of malaise with dizziness, sweating, vomiting and non-fluent aphasia.(b)(6) 2019, transthoracic ultrasonography was completed and a non-dilated left ventricle was observed, left ventricle ejection fraction was 74%, normal aorta, presence of the bioprosthesis 23mm trifecta valve in a receding aortic position (grade 1), with moderate stenosis and significant gradient increase.On (b)(6) 2019, the valve was explanted due to infective endocarditis, and it was replaced with a 21mm trifecta valve.The bioprosthesis cusps are thickened and remodeled, but there is no clear transthoracic vegetation.In the short axis, the ring is thickened and remodeled, possibly suggesting an abscess.No circulating flow.Normal mitral valve.In the short axis, the ring is thickened and remodeled, possibly suggesting an abscess.No circulating flow.Normal mitral valve.Normal left ventricular filling pressures.The left atrium was undilated.Normal right atrium.Normal non-dilated right ventricle, normal systolic function indices.Minimal tricuspid insufficiency (grade1/4).Normal pulmonary valve.The explanted valve was almost not damaged and in a good condition.On the other hand, there is a sub-annular obstruction explaining the significant gradients due to the stall by the abscess which makes about 2/3 of the circumference which goes on the right coronary up to half of the circumference at the level of the left coronary.Annular dimensions of the native valve was not available.The reason for replacing the 23mm trifecta valve with a 21mm trifecta valve was unknown.

Manufacturer Narrative

As reported in a research article, a valve was explanted after about four ears due to endocarditis.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 cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 medical device problem code: code 1153 removed.

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 66 year old patient due to syncopal calcified aortic stenosis.On (b)(6) 2015, a bioprothesis was seen in the aortic position with minimal leakage observed.The average gradient was measured to be 10mm and no stenosis was noted.The valve was non-dilated, non-hypertrophied left ventricle, there was normal left ventricular systolic function, the ejection fraction was 55-60%, and the straight cavities were un-dilated.There were no abnormal segment kinetics, no hypertension, and no pericardial effusion noted.The patient was hospitalized in the neurology ward on 30 june 2019 to 04 july 2019 for management of an ischemic stroke.An echography was performed on 4 july 2019, and endocarditis was seen on the aortic bioprosthesis, with the appearance of a potential non-circulating abscess of the posterior annulus, extending towards the mitral-aortic trigone.Of the two vegetations, one measured 11mm in length.No fistula or periprosthetic leak was observed.The patient tested positive three times for staphylococcus and began antibiotic (atb) therapy immediately.The patient was transferred to the cardiology unit.The patient had symptoms of malaise with dizziness, sweating, vomiting and non-fluent aphasia.(b)(6) 2019, transthoracic ultrasonography was completed and a non-dilated left ventricle was observed, left ventricle ejection fraction was 74%, normal aorta, presence of the bioprosthesis 23mm trifecta valve in a receding aortic position (grade 1), with moderate stenosis and significant gradient increase.On (b)(6) 2019, the valve was explanted due to infective endocarditis, and it was replaced with a 21mm trifecta valve.The bioprosthesis cusps are thickened and remodeled, but there is no clear transthoracic vegetation.In the short axis, the ring is thickened and remodeled, possibly suggesting an abscess.No circulating flow.Normal mitral valve.In the short axis, the ring is thickened and remodeled, possibly suggesting an abscess.No circulating flow.Normal mitral valve.Normal left ventricular filling pressures.The left atrium was undilated.Normal right atrium.Normal non-dilated right ventricle, normal systolic function indices.Minimal tricuspid insufficiency (grade1/4).Normal pulmonary valve.The explanted valve was almost not damaged and in a good condition.On the other hand, there is a sub-annular obstruction explaining the significant gradients due to the stall by the abscess which makes about 2/3 of the circumference which goes on the right coronary up to half of the circumference at the level of the left coronary.Annular dimensions of the native valve was not available.The reason for replacing the 23mm trifecta valve with a 21mm trifecta valve was unknown.No additional information was reported.

• 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: 16727288
• MDR Text Key: 313190034
• Report Number: 2135147-2023-01600
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2017
• Device Model Number: TF-A
• Device Catalogue Number: TF-23A
• Device Lot Number: 5095502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR