Coronary stents

Drug-eluting coronary stents
MHRA is aware of information presented at both the European Society of Cardiology1 meeting, and the American College of Cardiology Scientific Sessions2 which heightened concern over the risk of late stent thromboses associated with drug-eluting coronary stents.

MHRA has been actively monitoring the performance of coronary stents, including drug-eluting stents and continues to do so. MHRA investigates all adverse incident reports received from both stent manufacturers and clinicians. Our evaluation of these reports to date does not indicate that drug-eluting stents are less safe than non drug-eluting coronary stents. The assessment of the safety of drug-eluting coronary stents is a complex issue. There are different short and long term advantages and disadvantages depending on stent type and the whole picture needs to be taken into account. MHRA will continue to assess the safety of drug-eluting coronary stents in consultation with clinical professionals and the relevant manufacturers as more information on their long term performance becomes available. It is there fore important that clinicians continue to report all stent related adverse events to our Adverse Incident Centre.

1 September 2006, European Society of Cardiology Annual Meeting/World Congress of  Cardiology meeting in Barcelona, Spain. Safety of drug-eluting stents: insights from a meta-analysis. Presented by Alain Nordmann (University Hospital of Basel, Switzerland) 

2 March 2006, 55th Annual Scientific Sessions of the American College of Cardiology  Atlanta Georgia. Basket-Late (Basel stent cost-effectiveness trial - Late thrombotic events). Presented by Dr. Matthias E. Pfisterer of University Hospital in Basel, Switzerland

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Vigilance
Guidance on the Medical Devices vigilance system for CE marked coronary stents (521Kb) .

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MHRA safety warnings on coronary stents
MDA/2004/036 - Boston Scientific: Taxus™ Express2™ Paclitaxel-Eluting Coronary Stent Systems; Express2™ Coronary Stent Systems
Extension of recall relating to potential balloon deflation problems during coronary stent deployment.

MDA/2004/033 - Boston Scientific: Taxus® Express2® Paclitaxel-Eluting Coronary Stent Systems, Express2® Coronary Stent Systems
Recall of certain batches due to potential balloon deflation problems during coronary stent deployment.

DA 2002(10) - NIRoyal Coronary Stent: radial stent fracture after implantation
There have been nine reports of radial fractures of NIRoyal coronary stents occuring at varying times after implantation. In eight cases the patients presented with recurrent angina.