Events

Rappel de Device Recall EV3 EverFiex" Selfexpanding Peripheral 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
    74276
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2048-2016
  • Date de mise en oeuvre de l'événement
    2016-05-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-09-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147048
  • 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, superficial femoral artery - Product Code NIP
  • Cause
    Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two protege everfiex" self-expanding peripheral stent systems, model prb35-08-040- 080, from lot a164580. the size on the outer box is labeled as 8x40x80mm while potentially containing a 6x40x120mm device as indicated by both the inner pouch and device labels. this potential issue is limited to two everfiex stent system devices from lot a164580 that were repackaged by medtronic and distributed. this does not affect any other medtronic product or implantable devices.
  • Action
    Medtronic sent an "Urgent Medical Device Recall" letter dated May 2016, to all affected customers. The letter described the problem and the product involved in the recall. Consignees were instructed to identify, quarantine and return unused product to Medtronic. Consignees were requested to complete the Customer Confirmation Certificate and email it to RS.CFQFCA¿Medtronic.com or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. Customers with questions were instructed to call 651-367-0612. For question regarding this recall call 763-398-7000.

Device

Device Recall EV3 EverFiex" Selfexpanding Peripheral Stent System
  • Modèle / numéro de série
    lot: A164580
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to LA and WI.
  • Description du dispositif
    EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. || The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 F, 0.035" over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency
  • 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