Events

Recall of Device Recall PROTEGE EVERFLEX SELFEXPANDING BILIARY STENT SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ev3, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53867
  • Event Risk Class
    Class 2
  • Event Number
    Z-0478-2010
  • Event Initiated Date
    2009-11-06
  • Event Date Posted
    2009-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86726
  • Notes / Alerts
    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.
  • Extra notes in the data
    Catheter, biliary, diagnostic - Product Code FGE
  • Reason
    Ev3 has determined that a lot of 150mm prot¿g¿ everflex biliary stent system contains a 100mm length self-expanding stent. the implantation of a stent 50mm shorter than expected may not cover the full length of the target lesion and may require subsequent intervention.
  • Action
    Two separate letters were sent to United States and international consignees on November 9, 2009. The letter to US consignees was addressed to Cath Lab Managers while the letter to foreign consignees was addressed to the Risk Manager or Cath Lab Manager. The letters described the affected product, gave an Issue Summary and Required Action, which advised consignees to locate and remove the recalled product. An Ev3, Inc. sales representative will contact consignees to arrange return of all unused product to Ev3, Inc. Direct questions regarding the recall to Ev3, Inc. by calling Customer Service at 1-800-716-6700.

Device

Device Recall PROTEGE EVERFLEX SELFEXPANDING BILIARY STENT SYSTEM
  • Model / Serial
    United States lot # 7821740 and  Outside United States lot # 7821736
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States (TX and FL), GERMANY, FRANCE and UNITED KINGDOM.
  • Product Description
    Prot¿g¿ EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. || Prot¿g¿ EverFlex" Self-Expanding Peripheral Stent System (for Outside United States distribution). 6 x 100mm, Model Number PRP35-06-100-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. || In the United States, the stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the United States, it is intended indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, superficial femoral, proximal popliteal, or subclavian arteries.
  • Manufacturer
    Ev3, Inc.

Manufacturer

Ev3, Inc.
  • Manufacturer Address
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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