Events

Recall of Absorb Bioresorbable Vascular Scaffold (BVS) System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Abbott Vascular Division of Abbott Australasia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00517-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-04-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00517-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Abbott vascular advises that, effective immediately, the absorb bioresorbable vascular scaffold (bvs) system will only be available for use in clinical registry and special access settings. data from recent analyses have demonstrated that optimal implantation technique is critical to achieving good clinical outcomes. limiting use of this device to select hospitals/institutions will enable abbott to collect additional data and monitor implantation techniques. in light of recent concerns over elevated rate of major adverse cardiac events, specifically, myocardial infarction and scaffold thrombosis, abbott vascular awaits further data to confirm whether improved implantation techniques will mitigate these higher event rates.
  • Action
    Abbott Vascular has removed the product from the ARTG and is recalling all stock from the market until further notice. For further information please see https://www.tga.gov.au/alert/absorb-bioresorbable-vascular-scaffold-system .

Device

Absorb Bioresorbable Vascular Scaffold (BVS) System

Manufacturer

Abbott Vascular Division of Abbott Australasia Pty Ltd
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA