Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Medtronic SA.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 036 08 16 001
  • Event Initiated Date
    2016-08-31
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9917
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2016-RN-01015-1
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    A review was completed of all evolut r product complaints that indicated vascular trauma during use of the enveo r delivery catheter system (dcs) from the date of the first commercial evolut r product (august 2014) through may 2016. this review identified a total of 39 events (occurrence rate of 0,136%), each of which reported insertion, advancement, or positioning difficulties associated with complicated patient anatomy (tortuosity, calcification, bicuspid valve, or existing bioprosthesis). the cause of these vascular trauma complaints has been determined to be related to the difficulties maneuvering the enveo dcs in tortuous or highly calcified patient anatomy, which resulted in physicians manipulating or applying extra force to the dcs, leading to vascular trauma in a small sub-set of attempted evolut r implants. there is no indication of any non-conformance or failure of the dcs to meet requirements.

Device

EnVeo R Delivery Catheter System
  • Model / Serial
    Model number: ENVEOR-L ……………………… TGA update code : Models: ENVEOR-L-C
  • Product Description
    Aortic transcatheter heart valve bioprosthesis
  • Manufacturer
    Medtronic SA

Manufacturer

Medtronic SA
  • 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.
  • Manufacturers representative
    Medtronic Saudi Arabia
  • Source
    SFDA