Events

Alerte De Sécurité sur Misago Self-expanding Peripheral Stent ### Technical Name: Misago Self-Expansion Peripheral Stent ### Registration Number ANVISA: 80012280143 ### Risk Class: III (High Risk) ### ) affected: ALL ### Lot (s): EVERYTHING AND ANY LOT MANUFACTURED SINCE 2013

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Terumo Medical do Brasil; Terumo Coorporation.

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
    Safety alert
  • ID de l'événement
    1973
  • Date
    2016-08-25
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    (1). Customers should discontinue use immediately, and quarantine any available inventory products of batch numbers / product codes attached. (2). Distributors should stop immediately distributing any of the batch numbers / codes from the enclosure, quarantine any available inventory, and send this recall notice immediately to each customer who received these products to inform them of this problem. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Cause
    Terumo medical of brazil is initiating this recall based on internal research and tests performed by the manufacturer which revealed that during final tests for the release of the misago® self-expanding peripheral stent, it was found that they did not conform to the specifications defined in regulatory submissions regarding the diameter of the stent at the proximal / distal ends after self-expansion and / or stent shape. the investigation has determined that the compression forces applied to the stent during its assembly in the release catheter can cause minimal deformation and / or overlap in the stent rods. this may result in reduced diameter at the ends of the stent during deposition due to incomplete expansion, or in deformation in the shape of the stent, such as bending or inconsistent alignment of the stent rods.
  • Action
    Field Action Code Recall Voluntary Self-expanding Misago Stent triggered under the responsibility of the company Terumo Medical do Brasil. Retrieval for further destruction.

Device

Misago Self-expanding Peripheral Stent ### Technical Name: Misago Self-Expansion Peripheral Stent...

Manufacturer

Terumo Medical do Brasil; Terumo Coorporation