Events

Safety Alert for Lotus 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
    2016-08-04
  • Event Date Posted
    2016-08-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160804a.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 valve system medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its lotus valve system [upn: h749ltv230, h749ltv250, h749ltv270, h749ltvr3cl230, h749ltvr3cl250, h749ltvr3cl270]. the manufacturer is implementing a voluntary fsca for the lotus valve system to remove units from the field that were manufactured prior to a component related change made in march 2016. products manufactured after the implementation of this change are not impacted. there is no additional safety issue for patients who previously received a lotus implant since the issue only involves the delivery system and is not related to the performance of the implanted valve. according to the manufacturer, this action is related to a release mandrel breaks. the release mandrel is a component of the delivery system that is connected to the release pin which facilitates release of the valve from the delivery system. the manufacturer has not received any reports of release mandrel breaks for units built after the component change in march 2016. there was a number of release mandrel breaks reported for product manufactured prior to the component change. the most common outcome was resheating and removing the device without difficulty, resulting in procedural prolongation. however, the most severe outcome was catastrophic vessel trauma associated with patient death, which was reported in three cases. the manufacturer is now taking action to remove all units from the field that were manufactured prior to the change. the affected users are instructed to quarantine the affected products. 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 4 august 2016.

Device

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