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Device specific vigilance guidance: Coronary Stents and associated delivery systems

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Document information
ByMedicines and Healthcare products Regulatory Agencyamber_mesa_003c75

Guidance for manufacturers of coronary stents. It outlines specific scenarios that should be considered when determining if an incident is reportable.

Adapted edition

Medical device safety
Document type
Reference Guide
Format
DOCX
Pages
3
Language
English
Version
1.0
Updated
2026-09-17
Category
Safety & operations
Licence
Open Government Licence v3.0
Description

Guidance for manufacturers of coronary stents. It outlines specific scenarios that should be considered when determining if an incident is reportable. Consult the original guidance for current legal and operational details.

Contents
  • What should be reported
  • Report as individual incidents (in line with reporting timescales for serious incidents)
  • Clinical / Symptomatic (IMDRF ANNEX E codes)
  • Device (IMDRF ANNEX A codes)
  • Incidents that may be included in periodic summary reports (PSR) on agreement
  • Clinical / Symptomatic (IMDRF ANNEX E codes)
  • Device (IMDRF ANNEX E codes)
  • Trend Reporting - report at the time of a significant increase in the frequency or severity of incidents
  • Clinical / Symptomatic (IMDRF ANNEX E codes)
  • Device (IMDRF ANNEX E codes)
  • Clinical Reference Guidelines
Source and licence
Device specific vigilance guidance: Coronary Stents and associated delivery systems

Medicines and Healthcare products Regulatory Agency

Original source OGL-UK-3.0

AttributionMedicines and Healthcare products Regulatory Agency, ‘Device specific vigilance guidance: Coronary Stents and associated delivery systems’ (updated 16 June 2025), reused under the Open Government Licence v3.0.

ChangesNeutral text-only adaptation from the official GOV.UK Content API body: headings, paragraphs, ordered and unordered list items and clickable source-link destinations in an appendix preserved. Images, logos, page design, accessible-format request widgets and linked attachments excluded; normalised whitespace, invisible format marks and typography.

Version history
  • v1.017/09/2026
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