Events

Alerte De Sécurité sur Misago Peripheral Self-Expanding Stent System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Terumo Corporation.

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
  • Date
    2016-08-12
  • Date de publication de l'événement
    2016-08-12
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_201608012a.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: terumo misago peripheral self-expanding stent system medical device manufacturer, terumo corporation, has issued a medical device safety alert concerning its misago peripheral self-expanding stent system. the affected devices are identified as follows:- product codes: all misago products starting with sf*f or sx-v lot number: all products on the market within the labeled expiration period (manufactured from september-2013 through august-2016) during the inspection process, the manufacturer identified a low occurrence rate of two types of non-conformances in comparison to the specifications as described in the regulatory applications: reduced diameter at one, or both ends of the stent due to incomplete self-expansion after release from the delivery catheter; and deformation of the stent strut shape due to the compression forces that are applied to compact, and mount the stent to the delivery catheter. according to the manufacturer, the body of clinical evidence as related to misago stents supports that clinical performance is not affected in that there are no new or additional complications, or adverse health consequences. the health hazard evaluation concluded that the nonconformity in the dimension (reduced diameter rat the ends of the stent), or in the stent shape (a bend or inconsistent alignment of the stent struts), will have no impact to safety, or effectiveness, of the product. therefore, there is no additional risk of serious health harm posed by these nonconforming products. the manufacturer has not received customer complaints, or adverse events, related to incomplete stent expansion, stent deployment failure, insufficient diameter, or stent deformation. product recall is ongoing. 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 12 august 2016.

Device

Misago Peripheral Self-Expanding Stent System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo Misago Peripheral Self-Expanding Stent System
  • Manufacturer
    Terumo Corporation

Manufacturer

Terumo Corporation