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-2016-RN-00987-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00987-1
  • 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 is issuing an update to the recall for product correction that was initiated on december 7, 2015 (tga ref: rc-2015-rn-01188-1) for all sizes of absorb bioresorbable vascular scaffold (bvs) system. the purpose is global alignment of absorb indication - increase from 2.0 mm to 2.5 mm in minimum target vessel diameter indicated for implantation of this coronary stent.Abbott vascular plans to align the indications for absorb across all geographies for reference vessel diameter and as such the indication section and target vessel diameter and ranges table of the ifu are being updated. patients who have had absorb scaffolds successfully implanted are not affected by this action.
  • Action
    Abbott Vascular are issuing revised Instructions for Use (IFU), and are advising users to ensure; When Performing Lesion Sizing and Preparation, the treated lesion length should be less than the nominal scaffolding length, with reference vessel diameters = 2.5 mm and = 3.75 mm (previously = 2.0 mm and = 3.8 mm). In small vessels (visually assessed reference vessel diameter = 2.75 mm), on-line QCA or intravascular imaging with intravascular ultrasound or optical coherence tomography is strongly recommended to accurately measure and confirm appropriate vessel sizing. If quantitative imaging determines a vessel size < 2.5 mm, do not implant the Absorb BVS / Absorb GT1 BVS. Under-expansion of the scaffold may result in scaffold movement. Care must be taken to properly size the scaffold to ensure that the scaffold is in full contact with the arterial wall upon deflation of the balloon. All efforts should be made to assure that the scaffold is not under dilated.

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