Device specific vigilance guidance: Coronary Stents and associated delivery systems
Guidance for manufacturers of coronary stents. It outlines specific scenarios that should be considered when determining if an incident is reportable.
This document should be read 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 associated with coronary stents 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 reporting timescales for serious incidents)
Clinical / Symptomatic (IMDRF ANNEX E codes)
Examples of incidents which meet the definition of a serious incident for individual reporting include:
- MI or heart failure (E061202)
- acute coronary arterial perforation / dissection leading to haemopericardium / pericardial effusion or tamponade (E0605)
- cardiogenic shock (E233601)
- 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)
- mechanical failure of the delivery system (e.g. fracture / breakage) (A140801 / A040103)
- mechanical failure of the stent, (e.g. fracture / collapse) during or after implant (A0401 / A040101 / A0413 / A051101)
- stent fragment migration or embolization after implantation (A0104 / A010402)
- difficulty deflating the delivery system balloon (A140101)
- other delivery system (positioning complications) e.g. failure to advance or malposition of device (A1502 / A150201 / A150204)
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)
- thrombotic occlusion / embolism (E050304 / E2328 / E0521)
or:
- in-stent re-stenosis (E233701)
or:
- target vessel or lesion revascularization
- all CVA (Stroke & TIA) within 12 months of PCI procedure. List acute, sub-acute and late strokes separately. This should be separated out by haemorrhagic or ischemic stroke (E0133 / E013302)
Device (IMDRF ANNEX E codes)
- in vivo stent deformation (e.g. longitudinal stent deformation) (A0406)
- pre / post stent deployment dislodgement in-vivo, with or without migration (stent embolism) (A0104 / A010402 / A0512 / A051201)
- incomplete stent apposition / expansion or excessive recoil, (despite correct adherence to IFU) that requires further intervention (A150203)
- other delivery system (device deployment, or withdrawal) complications (A15 / A150206 / A150207)
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)
- side branch occlusion (E0521 / E2328)
- distal emboli (tissue, thrombotic / thrombus, plaque) (E503 / E050304)
- acute peripheral artery injury / perforation / dissection (E0511 / E0515)
- non-fatal bleeding complications (e.g. haemorrhage), which may require transfusion (E0506)
- infection – local and / or systemic (E1906)
- peripheral vascular or nerve injury (E0123 / E0518)
- non-life threatening adverse reactions (E2335 / E0402)
Device (IMDRF ANNEX E codes)
- difficulty advancing the stent or crossing the lesion, associated with procedural or patient factors (A150203 / A150204)
Clinical Reference Guidelines
Clinical reference guidelines for a specific device may be of use to manufacturers when identifying incident examples and complications.
Current clinical guidelines for coronary stenting procedures, expert consensus statements and current analysis of complications have been published by the European Society of Cardiology.