Events

Rappel de Absorb Bioresorbable Vascular Scaffold (BVS) System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Abbott Vascular Division of Abbott Australasia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00517-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-04-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00517-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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