Events

Retiro De Equipo (Recall) de Absorb Bioresorbable Vascular Scaffold (BVS) System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Abbott Vascular Division of Abbott Australasia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00987-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-29
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00987-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “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