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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problem Degraded (1153)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment: article titled ¿ outcomes following initial multicenter experience with robotic aortic valve replacement: defining a path forward".

Event Description

The article, "outcomes following initial multicenter experience with robotic aortic valve replacement: defining a path forward", was reivewed.The article presented a prospective, multicenter study to report the initial 200 international cases performed, provide a status update on the progress of multicenter ravr adoption, and present recommendations on program development and training.Devices included in this study were trifecta valve, unknown mechanical valves, and unknown bioprosthetic valves.The article concluded that the present multicenter international experience highlights that in centers with established robotic experience, the ravr procedure is reproducible and safe with excellent early results.As more centers initiate ravr programs, a dedication to reproducible quality patient care remains paramount and the recommendations for team training provided in this report aims to assist this endeavor.[the primary and corresponding author was (b)(6), (b)(6) university, with corresponding email: (b)(6).The time frame of the study was from january 2020 to september 2023.A total of 212 patients were included in this study, of which only one was confirmed to have received an abbott device.The average age was 67 years and the average gender was male.Comorbidities included atrial fibrillation, hypertension, diabetes mellitus, peripheral artery disease, coronary artery disease, end stage renal disease, cerebrovascular accident, permanent pacemaker, regurgitation (mitral/tricuspid/aortic), severe aortic stenosis, unicuspid/bicuspid aortic valve.

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided summarized patient outcomes/complications of trifecta valve were reported in a research article in a subject population with multiple co-morbidities including atrial fibrillation, hypertension, diabetes mellitus, peripheral artery disease, coronary artery disease, end stage renal disease, cerebrovascular accident, permanent pacemaker, regurgitation (mitral/tricuspid/aortic), severe aortic stenosis, and unicuspid/bicuspid aortic valve.Some of the complications reported were surgical intervention, hospitalization, and structural valve deterioration; these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• 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: 18699418
• MDR Text Key: 336397658
• Report Number: 2135147-2024-00645
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SJM TRIFECTA VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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