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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: chimney stenting vs basilica for prevention of acute coronary obstruction during transcatheter aortic valve replacement the udi number is not known as the part and lot number were not provided.

Event Description

The article, "chimney stenting vs basilica for prevention of acute coronary obstruction during transcatheter aortic valve replacement", was reviewed.The article presented a retrospective, multi-center study to compare periprocedural and 1-year outcomes of chimney and bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (basilica) in transcatheter aortic valve replacement (tavr) patients at high risk of coronary obstruction (co).Devices included were: mitroflow and crown (sorin); trifecta, toronto, and portico (st.Jude/abbott); freedom solo; freestyle, mosaic, hancock, corevalve, evolut r/pro (medtronic); perimount, magna ease, inspiris resilia, and sapien 3/3 ultra/xt (edwards); perceval: vascuteck elan, cryolife homograft; myval meril; and acurate neo and symetis (boston scientific).The article concluded that chimney stenting and basilica effectively prevent tavr-induced acute co.Both techniques seem to have comparable acceptable periprocedural and 1-year outcomes.[the primary author was antonio mangieri, irccs humanitas research hospital, rozzano-milan, italy.The corresponding author was mohamed abdel-wahab, department of cardiology, heart centre leipzig at university of leipzig, leipzig, germany, with corresponding email: mohamed.Abdel-wahab@medizin.Uni-leipzig.De] the time frame of the study was from january 2015 to july 2022.A total of 168 patients were included in the study of which 23.1% of patients first received an abbott device.38% of patients undergoing reintervention received an abbott device as a secondary device.The average age was 79.79 years and the majority gender was male.Comorbidities included hypertension, diabetes, prior myocardial infarction, prior stroke/transient ischemic attack, peripheral artery disease, prior permanent pacemaker, prior coronary artery bypass graft, prior percutaneous coronary intervention, chronic kidney disease, aortic regurgitation, aortic stenosis, mitral regurgitation, heart failure.

• 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: 19144039
• MDR Text Key: 340603498
• Report Number: 2135147-2024-01758
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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