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)

Device specific vigilance guidance: Artificial Heart Valves