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Device Problem
Perivalvular Leak (1457)
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Patient Problems
Atrial Fibrillation (1729); Hemorrhage/Bleeding (1888); Renal Failure (2041); Thromboembolism (2654); Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449)
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Event Type
Injury
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Manufacturer Narrative
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In an research article, extended icu stay, post-operative paravalvular leak, stroke, renal failure, atrial fibrillation, pacemaker implant, bleeding/transfusion, thromboembolism, re-intervention, thrombosis, and transvalvular regurgitation were reported.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.
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Event Description
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The article, "incidence of valvular regurgitation and leaflet perforation by using automated titanium fasteners (corknot®) in heart valve repair or replacement: less usual than reported", was reviewed.This research article is a retrospective single study experience to investigate the incidence of valvular complications in patients where corknot was used and draw preliminary conclusions on the risks involved in using automated titanium suture fasteners in cardiac valve replacement and/or repair surgeries.Perimount magna ease valve, abbott trifecta gt aortic valve, medtronic mosaic valve, medtronic hancock ii valve, abbott epic valve, medtronic avalus valve, ats mechanical valve, and st jude mechanical valve were associated with the study.The article concluded that the feasibility of corknot® utilization in mitral and aortic valve surgeries.Additionally, incidence of corknot® related complications in heart valve repair or replacement surgery is less usual in our setting than previously reported.These results motivate the use of corknot® as a valid alternative with complete commitment.[the primary author of the article is faizus sazzad, md, department of cardiac, thoracic and vascular surgery, national university heart centre, 1e kent ridge road, singapore 119228, singapore, the correspondence author is theo kofidis, md, with corresponding email: tkofidis@yahoo.Com].Related manufacturing reference numbers: 3001883144-2021-00112 and 2648612-2021-00083.
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Search Alerts/Recalls
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