Events

Alerte De Sécurité sur Endurant Stent Graft System

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Medtronic Ireland || Medtronic Inc.

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
    R1703-83
  • Numéro de l'événement
    2008DM-0002693
  • Date
    2017-03-01
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=99
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer states that it has detected that the referenced devices may be more susceptible to presenting a variable permeability in the tissue that may be associated with the seizures observed in the initial implant procedure, during the implant procedure, this variation of the permeability may cause the surgeon to categorize a endophagetype iv (which normally resolves itself over time) as a type iii endoleak due to tissue breakage, since it may appear that the leak is localized rather than diffuse, leading to unnecessary secondary interventions, leading to the occurrence possible adverse events on the patient.

Device

Endurant Stent Graft System
  • Modèle / numéro de série
  • Description du dispositif
    The ENDURANT endoprosthesis system is designed to treat infrarenal abdominal aortic or aortic iliac aorticilies using an endovascular technique. Once placed within the ureurysm, the enduran stent offers an alternative permanent conduit for blood flow within the vascular system of the patient, since it excludes the aneurysmal sac from blood flow and pressure.
  • Manufacturer
    Medtronic Ireland || Medtronic Inc

Manufacturer

Medtronic Ireland || Medtronic Inc
  • 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
    NIDFSINVIMA