Events

Safety Alert for Enveo R catheter delivery system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medtronic Mexico S De R.L. De C.V || Medtronic Corevalve Llc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1608-327
  • Event Number
    2009DM-0004930
  • Date
    2016-08-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=128
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    The manufacturer informs about the recommendations to reduce the rate of vascular trauma events during the use of the enveo r catheter release system (dcs) and announces the future update of the instructions for use, in order to avoid the occurrence of potentially adverse events on the patient.

Device

Enveo R catheter delivery system
  • Model / Serial
    ENVEOR-L and ENVEOR-L-C, specific lots.
  • Product Description
    The COREVALVE system from Medtronic is intended for the replacement of a poor aortic heart valve trans-luminal porentrega. Its purpose is to restore normal function to the deficient aortic valve of the patient. The MEDtronic COREVALVE system is indicated for patients with symptomatic native aortic valve stenosis or a failure of the surgical bio-prosthesis of the valve (defined as deficient, stenosed, or both) that need replacement. of valve presenting vessels of ataxillary / subclavian or femoral access with diameters greater than oigual to 6 mm or ascending aortic access point (direct aortic) greater than or equal to 60mm from the basal plane.
  • Manufacturer
    Medtronic Mexico S De R.L. De C.V || Medtronic Corevalve Llc

Manufacturer

Medtronic Mexico S De R.L. De C.V || Medtronic Corevalve Llc
  • 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
    NIDFSINVIMA