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Catalog Number UNK TORONTO VALVE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Aortic Valve Stenosis (1717); Arrhythmia (1721); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Renal Failure (2041); Cardiac Tamponade (2226); Aortic Valve Insufficiency/ Regurgitation (4450); Unspecified Tissue Injury (4559)
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Event Date 12/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effect of malfunction reported in the article is captured under a separate medwatch report.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 analysis.
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Event Description
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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.
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Search Alerts/Recalls
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