Events

Recall of Absorb Bioresorbable Vascular Scaffold (BVS) System (Bioresorbable balloon expandable scaffold with bioresorbable polymeric drug coating mounted on a balloon dilatation catheter)

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-2015-RN-01188-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01188-1
  • 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 (av) has recently published the results of absorb iii, a clinical trial that compared the safety and effectiveness of absorb bvs to the xience, metallic drug eluting stent. learnings from an analysis of the absorb iii data and other published data have identified an impact on clinical outcomes following changes to procedural techniques. implementation of these techniques is expected to facilitate optimal clinical outcomes and reduce the possibility of thrombosis. av will be updating the instructions for use (ifu) with this information.
  • Action
    Until the updated IFU is available, users are advised to follow the key changes identified in the customer letter while performing lesion sizing and preparation and also, during scaffold deployment to achieve optimal scaffold apposition to the artery wall. AV is also reinforcing the importance of the IFU instructions (including ensuring the vessel size is > 2.0 and < 3.8 mm) and the key changes in letter to facilitate optimal clinical outcomes and reduce adverse events such as restenosis and thrombosis.

Device

Absorb Bioresorbable Vascular Scaffold (BVS) System (Bioresorbable balloon expandable scaffold wi...
  • Model / Serial
    Absorb Bioresorbable Vascular Scaffold (BVS) System (Bioresorbable balloon expandable scaffold with bioresorbable polymeric drug coating mounted on a balloon dilatation catheter)All sizesARTG Number: 214148
  • Manufacturer
    Abbott Vascular Division of Abbott Australasia Pty Ltd

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