Events

Alerta De Seguridad para Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS Systems

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Abbott.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-12-07
  • Fecha de publicación del evento
    2015-12-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151207a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: abbott vascular absorb bioresorbable vascular scaffold (bvs) and absorb gt1 bvs systems medical device manufacturer, abbott, has issued a medical device safety alert concerning absorb bioresorbable vascular scaffold (bvs) and absorb gt1 bvs systems. the manufacturer has recently published the results of absorb iii, a prospective randomized controlled clinical trial that compared the safety and effectiveness of the affected products to their metallic drug-eluting stent, xience. learning 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 the techniques is expected to facilitate optimal clinical outcome and reduced the possibility of thrombosis. according to the manufacturer, there is no need to return the affect products and patients who have had successfully implanted of the scaffolds are not affected by this action. the manufacturer is issuing field safety notice to inform the customers about the key changes and will update the instructions for use. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 december 2015.

Device

Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS Systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott Vascular Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS Systems
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • 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
    DH