The article, "mitral valve replacement in infants and children: experience using a 15 mm mechanical valve", was reviewed.The article reported a case study of patient weighing 4.35kg with transitional atrio-ventricular canal defect.It was reported on an unknown date, a 15mm sjm masters hp valve was implanted in the patient.It was later reported on an unknown date when the patient was 4.6 years old, a decision was made to perform a mitral valve replacement procedure.The 15mm masters valve was replaced with a 19mm unknown valve.The article concluded that compared to other similar studies, this study was distinguished by a lower rate of major adverse events than previously reported, durability of the device, and a rapid post operative recovery time.Appropriate and consistent anticoagulation is a significant challenge in this age group.[(b)(6).].
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As reported through a literature review a patient with transitional atrio-venticular canal defect and had mechanical heart valve (mhv - hp) implanted.A patient underwent a mitral valve replacement procedure.The 15mm masters valve was replaced with a 19mm unknown valve.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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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