Events

Safety Alert for SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Peripheral Vascular System (6F and 7F)

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by IDEV Technologies.

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
  • Date
    2012-04-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120412.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: idev technologies supera veritas® interwoven self-expanding nitinol stent peripheral vascular system (6f and 7f) the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning the supera veritas® interwoven self-expanding nitinol stent peripheral vascular system (6f and 7f), manufactured by idev technologies. according to the manufacturer, there were reports of a rare event in which the catheter tip was pulled off during use. the manufacturer has determined that the failure to adhere to the instructions for use appeared to be the root cause of these events. specifically, if the thumb slide on the catheter handle is not retracted and locked prior to catheter withdrawal, per the instructions for use, the catheter tip may catch on the introducer sheath and may be pulled off the catheter body. removal of the detached tip may be necessary, as determined by the physician. to date, the manufacturer is not aware of these incidents occurring when the instructions for use are followed and, no injuries have been reported. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Peripheral Vascular System (6F and 7F)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: IDEV Technologies SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Peripheral Vascular System (6F and 7F)
  • Manufacturer
    IDEV Technologies

Manufacturer

IDEV Technologies
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH