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

Model Number	TF-A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Endocarditis (1834); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The article, ¿percutaneous retrieval of an aortic valve vegetation causing severe regurgitation and cardiogenic shock¿, was reviewed.The article presents a case study of an 82-year-old woman with a history of atrial fibrillation, interstitial lung disease, and a bicuspid aortic valve complicated by severe aortic stenosis after two prior surgical valve replacements.It was reported that on an unknown date in 2017, a 19mm trifecta valve was implanted in a patient.It was later reported on an unknown date, the patient presented with dyspnea and transesophageal echocardiography showed a mobile vegetation (endocarditis lesion) on the valve causing severe aortic regurgitation.It was reported the patient completed antibiotic treatment when they experienced cardiogenic shock with end organ hypoperfusion.A decision was made to perform a transcatheter debulking of the vegetation.After snaring the vegetation, it was removed via electrocautery and promptly aspirated.A 23mm evolut valve was then implanted in the patient.The patient was discharged after the 4th day and was asymptomatic after 3 months.The article concluded severe bioprosthetic valve regurgitation is a life-threatening condition.Early recognition and a low threshold for mechanical support are key to avoid shock and preserve organ function.Percutaneous treatment is feasible in inoperable patients.[the primary and corresponding author for this article was claudia lama von buchwald, henry ford hospital, 2799 west grand boulevard, detroit, michigan 48202, usa, with corresponding email: clamav1@hfhs.Org].
Additional Manufacturer Narrative
Literature article: percutaneous retrieval of an aortic valve vegetation causing severe regurgitation and cardiogenic shock investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
As reported in a research article, a patient had a mobile vegetation found on the valve after an unknown implant duration.The vegetation was causing regurgitation of the valve.The vegetation was removed and a transcatheter valve was implanted.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, 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.

• 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: 17356112
• Report Number: 2135147-2023-03109
• Device Sequence Number: 6068687
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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 Model Number: TF-A
• Device Catalogue Number: TF-19A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female