Events

Safety Alert for MitraClip Mitral Valve Repair System

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

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
    2013-02-28
  • Event Date Posted
    2013-02-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130228.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
    Medical device safety alert: abbott mitraclip mitral valve repair system medical device manufacturer, abbott vascular, has issued a field safety notice concerning mitraclip mitral valve repair system (product number msk02st). abbott vascular has received a total of 4 reports since 2008 where the actuator knob of the clip delivery system was incorrectly turned in the clockwise direction during clip deployment. in the event that the actuator knob is incorrectly turned, the device may incur damage that prevents the deployment of the clip. additional medical intervention or conversion to surgery may then be required. the current inventory of product is acceptable for safe use following the steps highlighted in the instructions for use (ifu). patients that have had clips successfully implanted are not affected by this action. the manufacturer advises all users to consult the approved ifu that were distributed with each device, which contains important information for the proper clip deployment steps. specifically, step 17.2.2 states: “turn the actuator knob of the dc approximately 8 turns counterclockwise. if it is difficult to turn the actuator knob, confirm that the arm positioner moves freely. retract the actuator knob after it is fully unthreaded.” subsequent to this step, the following warning appears: “failure to stop turning the actuator knob when resistance is felt or turning the actuator knob in the clockwise direction may result in inability to deploy the clip.” furthermore, the manufacturer will add a directional arrow on the actuator knob of newly manufactured devices to aid in proper clip deployment. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 february 2013.

Device

MitraClip Mitral Valve Repair System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott MitraClip Mitral Valve Repair System
  • Manufacturer
    Abbott Vascular

Manufacturer

Abbott Vascular
  • 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