Events

Rappel de Device Recall Protg Rx Tapered Carotid Stent System

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 Ev3, Inc..

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
    69965
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0878-2015
  • Date de mise en oeuvre de l'événement
    2014-12-04
  • Date de publication de l'événement
    2014-12-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132042
  • 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
    Stent, carotid - Product Code NIM
  • Cause
    Two production lots of the protege rx tapered carotid stent systems (secx-10-7-40-135, lot # 9922452 & sepx-8-6-40-135, lot # 9922795) because of a product labeling error.
  • Action
    Consignees were sent on 12/4/2014 a Covidien "Urgent Field Safety Notice" letter dated 4th December 2014. The letter described the problem and the product involved in the recall. Advised consignees to quarantine, discontinue use of the device and return the product to Covidien. They also requested consignees to complete the "Recall Verification Form" and return it to Covidien. For questions, customers can contact their local Covidien Representative.

Device

Device Recall Protg Rx Tapered Carotid Stent System
  • Modèle / numéro de série
    Lot # 9922452
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
  • Description du dispositif
    ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. || Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
  • Manufacturer
    Ev3, Inc.

Manufacturer

Ev3, Inc.
  • Adresse du fabricant
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • 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