Absorb Bioresorbable Vascular Scaffold System

2 May 2017

Consumers and health professionals are advised that Abbott Vascular Australia, in consultation with the TGA, is issuing a hazard alert for Absorb Bioresorbable Vascular Scaffold (BVS) System in response to data from some recent studies showing elevated rates of heart attack and blood clot. Abbott Vascular Australia is also recalling all unused stock of this device and has removed it from the Australian Register of Therapeutic Goods (ARTG).

Absorb BVS System is an implanted medical device that opens blocked coronary arteries. It is fully absorbed by the body over time.

The decision to undertake this recall and remove Absorb BVS System from the ARTG was based on data from recent analyses that showed an elevated rate of major adverse cardiac events, specifically heart attack and blood clot, when compared to patients treated with an another alternate stent.

Advancements in implantation technique used in more recent studies show improvements in safety and decrease in the event rates.

Absorb BVS System will now only be available for use in Australia through clinical trials and the unapproved product pathways (Special Access Scheme and Authorised Prescriber Scheme). Limiting use of this device through clinical trials and access schemes will help reduce risks to patients by ensuring that optimal implantation technique is used, and will allow Abbott Vascular Australia to undertake additional monitoring and data collection.

Information for consumers

If you or someone you provide care for has an Absorb BVS System, talk to your health professional to ensure that you are receiving appropriate treatment and know the signs and symptoms of heart attack and blood clot.

If you experience any new cardiac-related symptoms, such as irregular heartbeats, chest pain, or shortness of breath, seek immediate medical attention.

You should always follow any directions provided by your health professional, including taking medicines, known as dual antiplatelet therapy (DAPT), to reduce the risks of heart attack and blood clot.

If you have any further questions or concerns about this issue, talk to your health professional.

Information for health professionals

Abbott Vascular Australia has written to health professionals who have implanted Absorb BVS System, providing further information about this issue, including details of the recall procedure.

If you are treating a patient who has received an Absorb BVS System, please be aware of this issue.

Advise patients of the signs and symptoms of adverse cardiac events and instruct them to seek clinical care if they experience any new symptoms. Additionally, advise them to continue taking DAPT as prescribed.

If you have any questions or concerns about this issue, contact Abbott Vascular Australia on 1800 550 939.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.