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Catalog Number UNK MECHANICAL HEART VALVE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arrhythmia (1721); Atrial Fibrillation (1729); Cardiac Arrest (1762); Stroke/CVA (1770); Endocarditis (1834); Intracranial Hemorrhage (1891); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)
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Event Date 04/01/1990 |
Event Type
Injury
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Manufacturer Narrative
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The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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The article, "benefits of on-x mitral valve replacement in cases of infective endocarditis", was reviewed.The article presented a retrospective, single center study investigated the hemodynamic efficacy of the on-x valve when used for mitral valve replacement (mvr) in cases of mitral valve infective endocarditis (ie).Devices included in this study were on-x (on-x life technologies inc.) and unknown sjm mechanical heart valve (st jude medical/abbott).The article concluded that the suggested reduction in left atrial load attributed to the use of the on-x valve in mvr for ie may reduce the incidence of postoperative atrial fibrillation.[(b)(6)].The time frame of the study was from (b)(6) 1990 and (b)(6) 2022.A total of (b)(4) patients were included in this study, of which 27 (67.5%) received an abbott device.The average age was 54.1 years and the gender majority was male.Comorbidities included hypertension, dyslipidemia, diabetes mellitus, renal dysfunction, chronic obstructive pulmonary disorder, atrial fibrillation, previous cardiac surgery, infective endocarditis, heart failure, uncontrolled sepsis, systemic embolic event, mobile vegetation, severe mitral regurgitation.Peri- and post-procedural complications included death, surgical intervention, hospitalization, mitral regurgitation, atrial fibrillation, paravalvular leak, infective endocarditis, intracranial hemorrhage, stroke, heart failure, cardiac arrest, arrhythmia "death in the sjm group was due to intracranial hemorrhage (n=1), stroke (n=1), congestive heart failure (n=2), sudden cardiac arrest due to ventricular arrhythmia (n=1), or was sudden and of unknown cause (n=1).".
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Manufacturer Narrative
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Summarized patient outcomes/complications of mechanical heart valve were reported in a research article in a subject population with multiple co-morbidities including hypertension, dyslipidemia, diabetes mellitus, renal dysfunction, chronic obstructive pulmonary disorder, atrial fibrillation and previous cardiac surgery.Some of the complications reported were surgical intervention, hospitalization, mitral regurgitation, atrial fibrillation, paravalvular leak, infective endocarditis, intracranial hemorrhage, stroke, heart failure, cardiac arrest, arrhythmia and patient death.It was reported that patient death in the sjm group was due to intracranial hemorrhage, stroke, congestive heart failure, sudden cardiac arrest due to ventricular arrhythmia, or was sudden and of unknown cause.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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Search Alerts/Recalls
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