Events

Rappel de Device Recall Axium Detachable Coil System QC21Helix

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Micro Therapeutics Inc, dba ev3 Neurovascular.

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
    55696
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0873-2012
  • Date de mise en oeuvre de l'événement
    2010-03-01
  • Date de publication de l'événement
    2012-01-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91587
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Device, neurovascular embolization - Product Code HCG
  • Cause
    Ev3 has initiated a voluntary removal of two lots of axium detachable coil system for product mislabeling as the lots were swapped in production.
  • Action
    Micro Therapeutics Inc, dba ev3 Neurovascular performed product recovery according to the following outline. a) Quality Assurance Department (QAD) was used to provide details of product distribution for the affected lots. b) Based on the Health Hazard Assessment, the risk was considered undesirable. c) The affected product was part of a limited market release for Physician Preference Testing. As the product was within control of ev3 employees, no public notification was performed. d) Quality Systems contacted the sales representatives identifying the part number, lot number and number of units sent, and a request to segregate and return the affected product was initiated. e) Product returned to ev3 Neurovascular was held in Restricted Stock pending complete device accountability and disposition. f) The ev3 Neurovascular Quality Assurance department scrapped the affected product. g) The ev3 Neurovascular Regulatory Affairs department was responsible for assuring documentation and appropriate notification to regulatory bodies as required.

Device

Device Recall Axium Detachable Coil System QC21Helix
  • Modèle / numéro de série
    Lot # 7964576
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of the UK, and France.
  • Description du dispositif
    Axium Detachable Coil System QC-2-1-Helix || The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae.
  • Manufacturer
    Micro Therapeutics Inc, dba ev3 Neurovascular

Manufacturer

Micro Therapeutics Inc, dba ev3 Neurovascular
  • Adresse du fabricant
    Micro Therapeutics Inc, dba ev3 Neurovascular, 9775 Toledo Way, Irvine CA 92618-1811
  • 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
    USFDA