Events

Rappel Ou Alerte De Sécurité sur Absorb Bioresorbale Vascular Scaffold BVS and Absorb GT1 Bioresorbale Vascular Scaffold BVS

Selon Central Drugs Standard Control Organization, ce/cet/cette rappel ou alerte de sécurité concerne un dispositif en/au/aux/à India qui a été fabriqué par Abbott Healthcare Pvt. Ltd..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Safety Alert
  • ID de l'événement
    31-307-MD/2017-DC (Re. Reg. 03)
  • Date
    2017-04-07
  • Pays de l'événement
    India
  • Source de l'événement
    CDSCO
  • URL de la source de l'événement
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notes / Alertes
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 India.
  • Notes supplémentaires dans les données
  • Cause
    Based on the three years clinical data analysis from absorb ii it has been observed that there is an over elevated rate of major adverse cardiac events, specifically, myocardial infarction and scaffold thrombosis.
  • Action
    The Indian agent M/s Abbott Healthcare Pvt. Ltd., has informed this office that the manufacturer has initiated a Field Safety Notice in European countries to communicate that product use will' be limited to established post-market registries to facilitate the collection of real-world evidence for Absorb BVSand Absorb GTl BVSsystems.

Device

Absorb Bioresorbale Vascular Scaffold BVS and Absorb GT1 Bioresorbale Vascular Scaffold BVS

Manufacturer

Abbott Healthcare Pvt. 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
    CDSCO