Events

Avis De Sécurité sur IntraStent Unmounted Balloon Expandable Stent

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Ev3.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2008(01)
  • Date
    2008-01-24
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/intrastent-unmounted-balloon-expandable-stent&id=9699f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer, ev3, has advised the irish medicines board (imb) of a recall of specific lots of the intrastent unmounted balloon expandable stent.    the manufacturer has confirmed that the following affected lot / serial numbers have been supplied to the irish market:    4206244, 1688027, 1979986, 3003378.
  • Action
    Ensure that the relevant personnel in your organisation are made aware of this recall. Determine if you have purchased the affected lots of this product. Quarantine and return any unused affected product to ev3, United Kingdom office (see address below). Advise the IMB if you have the affected product.

Device

IntraStent Unmounted Balloon Expandable Stent
  • Modèle / numéro de série
    4206244, 1688027, 1979986, 3003378
  • Description du dispositif
    IntraStent Unmounted Balloon Expandable Stent
  • Manufacturer
    Ev3

Manufacturer

Ev3
  • 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
    HPRA