Events

Safety Alert for Lotus Edge Valve System

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

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
    2016-11-02
  • Event Date Posted
    2016-11-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161102.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: boston scientific lotus edge valve system medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its lotus edge valve system [upn: h749lvs230, h749lvs250, h749lvs270, h749lvscl230, h749lvscl250, h749lvscl270]. the manufacturer is implementing a voluntary field safety corrective action for the recently launched lotus edge valve system to remove all units from the field. there have been seven reports where the valve could not be fully locked and released. in six cases, the valve was retrieved and removed, resulting in procedure prolongation. in one case the valve was positioned in the descending aorta. in all seven cases, the patient was successfully treated with a new valve. the manufacturer has not received any reports of other serious adverse events associated with this failure mode. however, potential complications could include stroke and/or vessel trauma. according to the manufacturer, there is no safety issue for patients who previously received a lotus edge valve since the issue only occurs during the implant procedure and does not impact the performance of the implanted valve. product recall is on-going. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 november 2016.

Device

Lotus Edge Valve System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Boston Scientific Lotus Edge Valve System
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH