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This document should be read in conjunction with guidance on post market surveillance.ÌýÌý

»Ê¹ÚÌåÓýapp aim of this guidance is to complement the requirements ofâ€�. You should read it in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements. Â�

What should be reported 

»Ê¹ÚÌåÓýapp following examples indicate how to report device performance problems associated with coronary stents that caused or contributed to an incident. »Ê¹ÚÌåÓýapp examples are for illustrative purposes only and do not constitute an exhaustive list.ÌýÌý 

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. 

»Ê¹ÚÌåÓýapp 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)ÌýÌý

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)ÌýÌý
• cardiogenic shock (E233601)ÌýÌý
• 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. 

»Ê¹ÚÌåÓýapp following are examples of serious incidents for which PSR may be suitable: 

Clinical / Symptomatic (IMDRF ANNEX E codes)ÌýÌý

• thrombotic occlusion / embolism (E050304 / E2328 / E0521) 

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• in-stent re-stenosis (E233701) 

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• 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)ÌýÌý

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 

»Ê¹ÚÌåÓýapp types of adverse incident where an increase could have a significant adverse impact on the required risk analysis are numerous. »Ê¹ÚÌåÓýappse 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 â€� local and / or systemic (E1906) 
• peripheral vascular or nerve injury (E0123 / E0518) 
• non-life threatening adverse reactions (E2335 / E0402) 

Device (IMDRF ANNEX E codes)ÌýÌý

• 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.ÌýÌý

Current clinical guidelines for coronary stenting procedures, expert consensus statements and current analysis of complications have been published by the .