Events

Rappel de Protege EverFlex Self-Expanding Peripheral Stent System containing all size variants of 5mm diameter stent in both 80cm and 120cm delivery catheters. Protege EverFlex Self-Expanding Peripheral Stent System containing all size variants of 200mm length stent in 6, 7, 8mm diameter stent in 120cm delivery catheters. (Vascular prosthetic stent)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par EV3 Australia Pty Limited.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2012-RN-00867-3
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-08-28
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00867-3
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Ev3 has identified a regulatory compliance issue with the protege everflex self-expanding peripheral stent system range of products. the majority of these products were included in the australian register of therapeutic goods under artg 151132. however, the additional sizes with the smallest diameter stent of 5mm and the 6-8mm stents of greatest length of 200mm were inadvertently released prior to the tga's review and approval for inclusion under artg 151132.
  • Action
    EV3 Australia is asking hospitals to quarantine the affected stent system in a controlled area. Ev3 is advising clinicians that availability of the affected stent system is limited to patients eligible under the Special Access Scheme. Alternatively, individual clinicians can apply to the TGA to become an Authorised Prescriber.

Device

Protege EverFlex Self-Expanding Peripheral Stent System containing all size variants of 5mm diame...
  • Modèle / numéro de série
    Protege EverFlex Self-Expanding Peripheral Stent System containing all size variants of 5mm diameter stent in both 80cm and 120cm delivery catheters. Protege EverFlex Self-Expanding Peripheral Stent System containing all size variants of 200mm length stent in 6, 7, 8mm diameter stent in 120cm delivery catheters. (Vascular prosthetic stent)Multiple Product Codes
  • Manufacturer
    EV3 Australia Pty Limited

Manufacturer

EV3 Australia Pty Limited
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA