Tga stent recall: absorb bioresorbable vascular scaffold system
What is the issue?
The Therapeutic Goods Administration (TGA) has recalled a particular stent in Australia – the Absorb Bioresorbable Vascular Scaffold System (Absorb BVS System) – which is used to open blocked coronary arteries.
It has been recalled due to recent studies showing an increased risk of adverse cardiac events – specifically heart attack and blood clot formation – when compared to patients who have an alternate stent.
The Department of Health is contacting the small number of public patients who have these devices implanted.
Am I at risk?
If you have had an Absorb BVS System implanted, you may have a slightly higher risk of adverse cardiac events, specifically heart attack and blood clot formation.
If you had any other type of stent implanted, you are not at risk due to this recall.
What should I do to find out whether I am at risk?
If you had an Absorb BVS System implanted in a Queensland Health public hospital, your treating clinician will be – or will already have been – in touch with you directly.
If you believe you had an Absorb BVS System implanted in a private facility or outside of Queensland, you should contact your treating clinician.
If you had any other type of stent implanted in a Queensland Health public hospital, you will not be contacted about this recall as it is not related to your stent.
What do I need to do next if I am at risk?
Talk to your health professional if you are unsure of the signs and symptoms of heart attack and blood clot.
If you experience any new or changed cardiac-related symptoms, such as irregular heartbeats, chest pain, or shortness of breath, seek immediate medical attention.
Which stents are not affected?
This recall applies to the Absorb BVS System only. All other stents are not affected by this recall.
Where can I get more information?
For further information see the links below: