Abbott Vascular Absorb Bioresorbable Vascular Scaffold (BVS)

Safety alert

27 March 2017

Consumers and health professionals are advised that the TGA has recently reviewed the 2 year data from clinical studies on the Absorb BVS. This data demonstrates an increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with the approved metallic XIENCE drug-eluting stent also manufactured by Abbott Vascular.

The BVS is implanted via angioplasty and functions to open blocked coronary arteries. It is fully absorbed by the body over time. The BVS was approved by the TGA in September 2013 (ARTG ID 214148).

These major adverse cardiac events included cardiac death, heart attack, need for an additional procedure to re-open the treated heart vessel, and were more likely when the device was placed in small coronary vessels.

The TGA is continuing to analyse these outcomes and to monitor the performance of the BVS in ongoing clinical studies and adverse event reporting.

Information for consumers

Patients that have been treated with a BVS should continue to take any anti-platelet medications prescribed by their health care providers.

If you (or someone you care for) have been treated with a BVS and you (or they) are experiencing any new cardiac symptoms such as irregular heartbeats, chest pain, or shortness of breath, you should seek clinical care.

Information for health professionals

Health care providers are advised to:

  • Use caution when selecting this device, in particular follow instructions for patient and target vessel selection, included in the BVS physician labeling.
  • Advise patients experiencing any new cardiac symptoms to seek clinical care.
  • Advise BVS patients to follow the recommendations for DAPT prescribed by their health care providers.

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.