Related manufacturing reference number: 2135147-2021-00151.The article, "transcatheter closure of mitral paravalvular leak via multiple approaches", was reviewed.This research article is a retrospective multi center experience to review the experiences with transcatheter closure of mitral paravalvular leak(pvl) after surgical valve replacement.Amplatzer septal occluder, amplatzer muscular ventricular septal occluder, amplatzer duct occluder and amplatzer vascular plug ii(avp ii) were associated with the study.There is no allegation of malfunction of the abbott devices.The article concluded that transcatheter mitral pvl closure requires complex catheter techniques.However, this minimally invasive treatment could provide reliable outcomes and shorter hospital stays in selected patients.The primary author of the article is yang liu, department of cardiovascular surgery, xijing hospital, air force medical university, xian, china.The correspondence author of the article is yang liu, department of cardiovascular surgery, xijing hospital, air force medical university, xian, china with the corresponding email: yangjian1212@hotmail.Com.The following report is being conservatively reported.
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As reported in a research article, patient death occurred following removal of a device used for off-label closure of paravalvular leakage which interfered with "the disk of the mechanical 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.This research was reported to have been conducted between january 2015 and december 2019.At this time, no amplatzer closure products were indicated for use for the closure of paravalvular leakage.
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