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

Catalog Number UNK SJM TRIFECTA VALVE

Device Problems Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Aortic Valve Stenosis (1717); Arrhythmia (1721); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Renal Failure (2041); Cardiac Tamponade (2226); Aortic Valve Insufficiency/ Regurgitation (4450); Unspecified Tissue Injury (4559)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Literature article: procedural and one-year outcomes of the basilica technique in europe: the multicentre euro-basilica registry summarized patient outcomes/complications of bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (basilica) in patients at high risk for coronary artery obstruction (cao) undergoing transcatheter aortic valve implantation (tavi) in a multicentre european registry (euro-basilica) were reported in a research article "procedural and one-year outcomes of the basilica technique in europe: the multicentre euro-basilica registry" in a subject population with multiple co-morbidities including coronary artery disease, prior percutaneous intervention, prior coronary artery bypass surgery, hypertension, diabetes mellitus, peripheral artery disease, prior myocardial infarction, prior stroke, pacemaker implant/implantable cardioverter defibrillator, pulmonary hypertension, kidney disease/injury, liver cirrhosis, oral anticoagulant, and aortic stenosis/regurgitation.Some of the complications reported were aortic stenosis, aortic regurgitation, degeneration, stroke, bleeding, rehospitalization, pacemaker implant, surgical intervention, cardiac tamponade, acute kidney injury, myocardial infarction, unspecified tissue injury, arrhythmia; 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 analysisna.

Event Description

The article, "procedural and one-year outcomes of the basilica technique in europe: the multicentre euro-basilica registry", was reviewed.The article presented a retrospective, multicenter study to evaluate the procedural and one-year outcomes of bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (basilica) in patients at high risk for coronary artery obstruction (cao) undergoing transcatheter aortic valve implantation (tavi) in a multicentre european registry (euro-basilica).Devices included in this study were evolut r, sapien 3, corevalve, perimount, hancock, inspiris reselia, mitroflow, trifecta, freestyle, freestyle-solo, toronto, elan, and cryolife homograft.The article concluded that euro-basilica is the first multicentre study evaluating the basilica technique in europe.The technique appeared feasible and effective in preventing tavi-induced cao, and one-year clinical outcomes were favourable.The residual risk for cao requires further study.[the primary and corresponding author was mohamed abdel-wahab, heart center leipzig, university of leipzig, leipzig, germany, with corresponding email: mohamed.Abdel-wahab@medizin.Uni-leipzig.De] the time frame of the study was from december 2017 to october 2021.A total of 76 patients were included in the study, of which 18 (23.7%) received an abbott device.The average age was 79 years and the average gender was female.Comorbidities included coronary artery disease, prior percutaneous intervention, prior coronary artery bypass surgery, hypertension, diabetes mellitus, peripheral artery disease, prior myocardial infarction, prior stroke, pacemaker implant/implantable cardioverter defibrillator, pulmonary hypertension, kidney disease/injury, liver cirrhosis, oral anticoagulant, and aortic stenosis/regurgitation.

• 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: 18668624
• MDR Text Key: 334906826
• Report Number: 2135147-2024-00575
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

• Date FDA Received: 02/08/2024
• 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: 01/17/2024
• 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