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.

Report as individual incidents (in line with statutory timescales for serious incidents)

Examples of serious incidents which should be reported individually include:

Clinical / Symptomatic (IMDRF annex E codes)

pulmonary embolism (E050303)
injury to vasculature / IVC wall perforation (E0511 / E051101)
vascular access related problems eg: pneumothorax, air embolism, bleeding (haemorrhage / haematoma), intimal tear (E0734 / E050301 / E0506 / E0515)
injury to cardiac structures (E0604 / E0605)
anaphylaxis due to suspected adverse and or allergic reaction to a specific intrinsic material, substance or chemical, forming whole, part or contributing to the function of the medical device and or its packaging; including any residual material, substance or chemical, involuntarily introduced as part of the manufacturing process (E040201)

Device (IMDRF annex A codes)

complications during deployment, involving the delivery system or placement eg:
- premature release of filter (A150101 / A150303)
- partial deployment and or difficult retrieval of delivery system (A050501 / A150101 / A150102)
mechanical failure of the IVC filter (implant), partial or multiple fractures (A0401 / A040101)
device migration/secondary movement with or without embolization (A0512 / A1502)

Incidents that may be included in periodic summary reports (PSR) on agreement

If a PSR agreement is not granted, incidents should continue to be assessed and reported individually following guidance on post-market surveillance.

The following are examples of serious incidents for which PSR may be suitable:

Clinical / Symptomatic (IMDRF annex E codes)

IVC wall erosion / penetration >3mm. (E2006 / E2114 / E0511)

Device (IMDRF ANNEX E codes)

retrieval difficulties / failure to retrieve (A150207)
progressive tilting / angulation (A150208)

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)

IVC wall penetration <3mm (E2006 / E2114 / E0511)
vascular access related problems (E2124 / E0505)
inferior vena cava thrombosis, occlusion resulting in restriction of blood flow through the filter or venous insufficiency (E2328 / E050304)
infection – local and / or systemic (E1906)
non-life threatening adverse reactions (E2335 / E0402)

Device (IMDRF annex E codes)

device placement related problems (misplacement / improper placement) (A150202)
migration (A010402)
partial or incomplete expansion (A1501 / A040604)
deformation (such as crossed or twisted legs or arms) (A0406 / A040601)
asymmetric deployment (malposition)

Device specific vigilance guidance: Inferior vena cava (IVC) filters