{"id":1081,"date":"2017-11-13T14:58:06","date_gmt":"2017-11-13T14:58:06","guid":{"rendered":"https:\/\/www.groupactionlawyers.co.uk\/blog\/?p=1081"},"modified":"2017-11-13T14:58:06","modified_gmt":"2017-11-13T14:58:06","slug":"mechanical-heart-valves-alert-over-risk-inverted-implantation","status":"publish","type":"post","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/mechanical-heart-valves-alert-over-risk-inverted-implantation","title":{"rendered":"Medical device alert issued over bi-leaflet mechanical heart valves over risk of inverted implantation"},"content":{"rendered":"<p>Over the past 15 years, the Medicines and Healthcare product Regulation Agency (MHRA) has been made aware of five incidents where a mechanical bi-leaflet prosthetic valve has been implanted the wrong way round because they were put in the holders upside down. The MHRA is afraid that, due to under-reporting, many more injuries and deaths may have occurred as a result.<\/p>\n<p>The heart controls the blood flow in our bodies and relies on aortic valves to ensure the blood is pushed in the right direction to reach our organs and limbs. However, over time, these valves can become weak or damaged and don&#8217;t close properly which can lead to blood leaking back into the heart, making it much harder for the heart to pump it outwards to the rest of our bodies, resulting in heart failure. Artificial mechanical valves can be fitted to replace the weakened or thickened valve.<br \/>\n<!--more--><br \/>\nThe surgical procedure carries a low probability &#8211; yet extremely dangerous &#8211; risk of error if something goes wrong. Although the replacement valves are very durable and should last a long time, if the implanting procedure is carried out incorrectly, patients are put at risk.<\/p>\n<p>In the five reported cases, at least two are known to have been fatal. In terms of fault, the MHRA noted that:<\/p>\n<div class=\"well\">\n<ul class=\"blog-list\">\n<li>Two were because of the manufacturing quality control failure where the valves were loaded the wrong way (one of which lead to a fatality)<\/li>\n<li>One valve came apart from the holder during transportation and remounted just before implanting<\/li>\n<li>One valve was remounted during the valve surgery<\/li>\n<li>One valve was remounted the wrong way (leading to the patient&#8217;s death)<\/li>\n<\/ul>\n<\/div>\n<p>Manufacturers are urging surgeons and staff to <strong><em>not<\/em><\/strong> reattach a valve to its holder if it comes loose or breaks off to avoid these rare but potentially fatal errors. Notably, some manufacturers like St. Jude Medical (now Abbott) produce holders that are unidirectional <strong>so they can&#8217;t be put in the wrong way<\/strong> during assembly. <\/p>\n<p>The MHRA received confirmation that three other manufacturers will also redesign their holders this way to avoid any future reoccurrences of the problem.<\/p>\n<p>The MHRA believes the process of changing the manufacturing of the devices will take at least one year, and in that time they&#8217;re urging clinical staff and surgeons to familiarise themselves with the risks and how to spot any problems.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Over the past 15 years, the Medicines and Healthcare product Regulation Agency (MHRA) has been made aware of five incidents where a mechanical bi-leaflet prosthetic valve has been implanted the wrong way round because they were put in the holders upside down. The MHRA is afraid that, due to under-reporting, many more injuries and deaths &hellip; <a href=\"https:\/\/www.groupactionlawyers.co.uk\/blog\/mechanical-heart-valves-alert-over-risk-inverted-implantation\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Medical device alert issued over bi-leaflet mechanical heart valves over risk of inverted implantation<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":605,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[5],"tags":[20],"class_list":["post-1081","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","tag-mhra"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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In one of the complaints, one patient death is suspected to be related to the device. 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Manufactured by Intersurgical, the manual resuscitation system - named as the \"Bag valve mask\" (BVM) - risks damage to lungs due to the\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"unsatisfactory safety information","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert.png?fit=1200%2C414&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert.png?fit=1200%2C414&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert.png?fit=1200%2C414&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert.png?fit=1200%2C414&ssl=1&resize=700%2C400 2x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/medical-device-alert.png?fit=1200%2C414&ssl=1&resize=1050%2C600 3x"},"classes":[]},{"id":1282,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/histamine-alert-gentamicin-sulphate-active-pharmaceutical-ingredient","url_meta":{"origin":1081,"position":3},"title":"MHRA issues warning for Gentamicin Sulphate Active Pharmaceutical Ingredient over increased levels of histamine","author":"Admin","date":"17th January 2018","format":false,"excerpt":"The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert over batches of Gentamicin Sulphate Active Pharmaceutical Ingredient (API) for trace contamination of histamine. The situation is reportedly not serious enough to warrant a recall. Gentamicin is a bactericidal used an as active ingredient for antibiotics. The MHRA\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"mhra issue histamine alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/mhra-histamine-alert-min.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/mhra-histamine-alert-min.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/mhra-histamine-alert-min.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/mhra-histamine-alert-min.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":3147,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/patient-information-leaflet-problems-your-right-to-compensation","url_meta":{"origin":1081,"position":4},"title":"Patient Information Leaflet Problems: Your Right to Compensation","author":"Author","date":"26th August 2025","format":false,"excerpt":"Failure in the patient information leaflet problems can potentially endanger countless patients who depend on medications for treatment. In May 2025, the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a critical Class 4 Medicines Notification concerning multiple topical steroid products manufactured by Chemidex Pharma Ltd. The core issue lies\u2026","rel":"","context":"In &quot;Group Actions&quot;","block_context":{"text":"Group Actions","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/group-actions"},"img":{"alt_text":"patient information leaflet problems","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/ALSO-DBL-TVM-Images-Batch-6-YL-DLL-9-min.png?fit=653%2C436&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/ALSO-DBL-TVM-Images-Batch-6-YL-DLL-9-min.png?fit=653%2C436&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/ALSO-DBL-TVM-Images-Batch-6-YL-DLL-9-min.png?fit=653%2C436&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":1072,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/medical-device-alert-datascope-corp-intra-aortic-balloon-pumps","url_meta":{"origin":1081,"position":5},"title":"Medical device alert for Datascope Corp intra-aortic balloon pumps","author":"Admin","date":"8th November 2017","format":false,"excerpt":"The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for intra-aortic balloon pumps manufactured by Datascope Corp. Models CS100, CS100i and CS300 are reportedly at risk of \"haemodynamic instability to patients with critical care conditions due to a delay in, or sudden interruption of, therapy.\"\u2026","rel":"","context":"In &quot;Medical&quot;","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]}],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1081","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/comments?post=1081"}],"version-history":[{"count":2,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1081\/revisions"}],"predecessor-version":[{"id":1084,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1081\/revisions\/1084"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media\/605"}],"wp:attachment":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media?parent=1081"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/categories?post=1081"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/tags?post=1081"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}