# Device specific vigilance guidance: Artificial Heart Valves Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/e84402af-5d90-4749-a6ab-cb6cfb768432 Type: Detailed Guide Published: June 16, 2025 > This regulatory guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) provides instructions for manufacturers regarding post-market surveillance for surgical and transcatheter heart valves. While the document does not target a specific company or detail a single inspection, it applies to all manufacturers operating under the UK regulatory framework, specifically Statutory Instrument SI 2024 No. 1368. The guidance establishes a standardized approach to reporting device performance problems and clinical incidents using International Medical Device Regulators Forum (IMDRF) codes. Key issues identified for mandatory reporting include mechanical failures such as leaflet ruptures, stent fractures, and valve thrombosis, as well as clinical complications like vascular injury or myocardial infarction. For transcatheter heart valves, specific focus is placed on delivery system failures and valve malposition. Manufacturers are required to take specific actions: individual serious incidents must be reported within statutory timescales; periodic summary reports (PSR) may be utilized for certain events if prior agreement is granted; and trend reporting is mandatory when there is a significant increase in the frequency or severity of adverse events. These measures are designed to ensure continuous risk analysis and the ongoing safety of heart valve populations. --- ## Content You should read this document in conjunction with guidance on post-market surveillance . The aim of this guidance is to complement the requirements of SI 2024 No. 1368 . You should read it in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements. What should be reported The following examples indicate how to report device performance problems that caused or contributed to an incident. The examples are for illustrative purposes only and do not constitute an exhaustive list. If in an incident appears to meet criteria contained in more than one category, ensure it is included in submissions under each reporting format, even if this results in duplication of reporting for that incident. The IMDRF annex codes associated with each text description are included as guides. Biological / mechanical – surgical heart valves Report as individual events (in line with statutory timescales for serious incidents) Examples of serious incidents which should be reported individually include: Clinical / Symptomatic (IMDRF ANNEX E codes) injury to vasculature (E0511 / E0515) injury to cardiac structures (E0604 / E0605) myocardial infarction, cardiogenic shock (E061202 / E233601) Device (IMDRF ANNEX A codes) explantation / revision (possible or definite device failure) leaflet, cusp rupture / perforation / tearing / immobility / detachment from stent posts (E0608 / E0621 / E0622 / E0624 / E062101-4) fracture of the stent or valve structure (A040101) separation of sewing cuff from housing or stent (A0404 / A0413 / A0501) prosthesis thrombosis (E0514) valve contamination and or endocarditis (A18 / A1801 / A180104 / E0610) embolisation or migration of whole or part of the heart valve (A0104 / A010402) incidents relating to accessories, instrument failure or incompatibility (A1701 / A170101 / A170102 / A1702) Incidents that may be included in periodic summary reports (PSR) on agreement If a PSR agreement is not granted, reports should continue to be assessed and made individually following post market surveillance requirements guidance . The following are examples of serious incidents for which PSR may be suitable: Clinical / Symptomatic (IMDRF ANNEX E codes) valvular insufficiency, regurgitation or leak (central / peri / para / unknown aetiology) (A050405 / A05409 / A051105 / E0607 / E0621 / E062101-4) Device (IMDRF ANNEX E codes) structural deterioration causing stenosis (including Intrinsic / extrinsic mineralization or calcification) within 7 years of implantation (A0106 / E0622 / E062201-04) non-structural dysfunction (eg leaflet obstruction / entrapment by pannus in growth, suture/tissue dehiscence) (A0106 / E0622 / E062201-04) Trend Reporting - Report at the time of a significant increase in the frequency or severity of incidents The types of adverse incident where an increase could have a significant adverse impact on the required risk analysis are numerous. These may include the following examples: Clinical / Symptomatic (IMDRF ANNEX E codes) angina (E061201) cardiac arrhythmias (E0601 / E060101-6) fibrosis (E2313) haemolysis / haemolytic anaemia (E0303) haemorrhage, anticoagulation or antiplatelet-related event (E0506) infection – other than endocarditis (E19 / E2115 / E2205 / E2122) (numerous) myocardial infarction, cardiogenic shock (E061202 / E233601) overall mortality rate of valve population Device (IMDRF ANNEX E codes) valve distortion (eg inappropriate sizing) (A0406 / A040601) explantation - no common cause - within device life expectancy explantation within 24hrs following implantation Specific additional guidance for transcatheter heart valves (THV) Report as individual events (in line with statutory timescales for serious incidents) delivery system failure / complications leading to vascular or cardiac injury e.g. pericardial effusion or cardiac tamponade. premature deployment (A150303) migration / embolisation of valve (A0104 / A010402) malposition requiring further intervention (A150202) Incidents that may be included in periodic summary reports (PSR) on agreement If a PSR agreement is not granted, reports should continue to be assessed and made individually following post market surveillance requirements guidance . The following are examples of serious incidents for which PSR may be suitable: conduction system injury (E0601 / E060101-6) valvular insufficiency, regurgitation or leak (central / perivalvular - paravalvular / unknown aetiology - mild, moderate severe) (A050405 / A05409 / A051105 / E0607 / E0621 / E062101-4) Report at the time of a significant increase in the frequency or severity of incidents The types of adverse incident where an increase could have a significant adverse impact on the required risk analysis are numerous. These may include the following examples: delivery system failure / complications e.g. balloon inflation or deflation problems, difficulties removing delivery system (without injury) (A150204 / A150206 / A150207) complications linked with a transapical cardiac incision or balloon aortic valvuloplasty access site haematoma or inflammation (E0505) improper implantation location (potentially causing coronary flow obstruction or mitral valve impairment or damage) (A150202)