Le Center for Devices and Radiological Health (CDRH) de la Food and Drug Administration (FDA) des \u00c9tats-Unis publie une alerte pr\u00e9coce concernant un probl\u00e8me potentiellement \u00e0 haut risque touchant des dispositifs m\u00e9dicaux de cardiologie interventionnelle. L\u2019alerte concerne certains syst\u00e8mes de d\u00e9livrance Commander M utilis\u00e9s dans le cadre du syst\u00e8me de remplacement valvulaire mitral par voie transcath\u00e9ter SAPIEN M3 (transcatheter mitral valve replacement). Selon la FDA, l\u2019entreprise Edwards Lifesciences a adress\u00e9 le 5 octobre une lettre aux clients concern\u00e9s, leur recommandant de retirer de l\u2019usage ou de la vente les dispositifs appartenant aux lots suivants : 67718561, 67804014, 67887043 et 67887044. Les unit\u00e9s portant d\u2019autres num\u00e9ros de lot ne sont pas concern\u00e9es et peuvent continuer \u00e0 \u00eatre utilis\u00e9es.<\/p>\n
Edwards Lifesciences indique avoir re\u00e7u trois signalements de rupture de ballon lors du gonflage. Les complications possibles incluent une embolie et l\u2019impossibilit\u00e9 de retirer le dispositif par la gaine de guidage, pouvant n\u00e9cessiter des interventions suppl\u00e9mentaires, y compris chirurgicales. Ces interventions sont consid\u00e9r\u00e9es comme particuli\u00e8rement \u00e0 risque pour cette population de patients jug\u00e9s non \u00e9ligibles \u00e0 la chirurgie, avec un risque \u00e9lev\u00e9 de cons\u00e9quences graves pour la sant\u00e9, y compris le d\u00e9c\u00e8s. Au 5 octobre, l\u2019entreprise fait \u00e9tat d\u2019un d\u00e9c\u00e8s et d\u2019une blessure grave associ\u00e9s \u00e0 ce probl\u00e8me.<\/p>\n
Les syst\u00e8mes de d\u00e9livrance Commander M sont destin\u00e9s \u00e0 acheminer une valve mitrale cardiaque de remplacement jusqu\u2019au c\u0153ur via les vaisseaux sanguins, sans chirurgie \u00e0 thorax ouvert. La FDA recommande de ne pas utiliser les produits identifi\u00e9s comme affect\u00e9s, de rechercher et retirer ces dispositifs des stocks, et de les renvoyer \u00e0 Edwards Lifesciences en lien avec le repr\u00e9sentant de l\u2019entreprise. Les \u00e9tablissements sont invit\u00e9s \u00e0 diffuser l\u2019information au sein des \u00e9quipes cliniques concern\u00e9es et \u00e0 consulter r\u00e9guli\u00e8rement la page d\u00e9di\u00e9e de la FDA pour d\u2019\u00e9ventuelles mises \u00e0 jour. La FDA poursuit l\u2019analyse de ce probl\u00e8me de dispositif \u00e0 risque potentiellement \u00e9lev\u00e9 et annonce qu\u2019elle informera le public en cas de nouvelles informations significatives.<\/p>\n
Aux \u00c9tats-Unis, les professionnels de sant\u00e9 et les patients sont encourag\u00e9s \u00e0 signaler \u00e0 la FDA, via le programme MedWatch, tout effet ind\u00e9sirable ou probl\u00e8me de qualit\u00e9 li\u00e9 \u00e0 ces dispositifs. Les clients am\u00e9ricains peuvent \u00e9galement contacter directement Edwards Lifesciences (num\u00e9ro de t\u00e9l\u00e9phone et adresse \u00e9lectronique d\u00e9di\u00e9s) pour toute question ou pour la gestion des dispositifs impact\u00e9s. Cette situation illustre un cas de vigilance renforc\u00e9e sur un dispositif de cardiologie \u00e0 haut risque, impliquant une coordination entre l\u2019autorit\u00e9 de r\u00e9gulation (FDA), le fabricant et les utilisateurs en \u00e9tablissement de sant\u00e9. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le Center for Devices and Radiological Health (CDRH) de la Food and Drug Administration (FDA) des \u00c9tats-Unis publie une alerte pr\u00e9coce concernant un probl\u00e8me potentiellement \u00e0 haut risque touchant des […]<\/p>\n","protected":false},"author":1,"featured_media":17780,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[260,227,226],"class_list":["post-21223","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-fda","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21223","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21223"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21223\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17780"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21223"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21223"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21223"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}