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Catalog Number UNK MECHANICAL HEART VALVE |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Ventricular Fibrillation (2130); Heart Failure/Congestive Heart Failure (4446)
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Event Date 03/01/1990 |
Event Type
Injury
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Event Description
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The article, ¿outcomes after mechanical aortic valve replacement in children with congenital heart disease¿, was reviewed.The article presented a retrospective single center study that investigated the outcomes following avr using mechanical prostheses in children.Devices included in this study were st.Jude (abbott, santa clara, ca, usa), on-x (cryolife, kennesaw, ga, usa), ats (medtronic, minneapolis, mn, usa), and mira (edward lifesciences, irvine, ca, usa).The article concluded mechanical avr could be performed safely in children.Younger age, longer cardiopulmonary bypass time and smaller valve size were associated with adverse events.Thromboembolic or hemorrhagic complications might rarely occur.[the primary and corresponding author was chun soo park, division of pediatric cardiac surgery, asan medical center, university of ulsan college of medicine, seoul, with corresponding email: chunsoo@amc.Seoul.Kr].
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Manufacturer Narrative
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Summarized patient outcomes/complications of outcomes after mechanical aortic valve replacement in children with congenital heart disease were reported in a research article in a subject population with multiple co-morbidities including aortic stenosis, aortic regurgitation, bicuspid/quadricuspid aortic valves, congenital aortic valve disease, conotruncal anomaly, connective tissue disorder, marfan syndrome, loeys-dietz syndrome, turner syndrome, noonan syndrome/charge syndrome, prior catheter-based or surgical intervention, prior procedure for aortic valve.Some of the complications reported were death, heart failure, ventricular tachycardia, surgical intervention, hospitalization, pannus 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.The additional patient effects and malfunctions reported in the article are captured under separate reports.Literature attachment: article title: outcomes after mechanical aortic valve replacement in children with congenital heart disease.
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Search Alerts/Recalls
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