Events

Rappel de Solitaire Platinum Revascularisation Device

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

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-2017-RN-01107-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-08-23
  • 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-2017-RN-01107-1
  • 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
    Medtronic is advising that the instructions for use (ifu) included with solitaire platinum revascularisation devices supplied to date do not have correct information regarding indication for use in australia as approved by the tga:the solitaire platinum revascularisation device is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (iv t-pa). endovascular therapy with the device should be started within 6 hours of symptom onset; and the device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. patients who are ineligible for iv t-pa or who fail iv t- pa therapy are candidates for treatment.
  • Action
    Refer to the Instructions for Use included with the customer letter. Continued use of the Solitaire Platinum product as per the TGA approved indication for use is permissible. Complete the Customer Confirmation form supplied with the customer letter and fax it to Medtronic. Share this notification and the included Instructions for Use with others as appropriate, and contact Medtronic Territory Managers with any questions related to this product recall.

Device

Solitaire Platinum Revascularisation Device
  • Modèle / numéro de série
    Solitaire Platinum Revascularisation DeviceProduct Codes: SRD3-4-20-10, SRD3-4- 40-10, SRD3-6-20-10 and SRD3-6-40-10ARTG Number: 284964
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • 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