Events

Safety Alert for Eluting Coronary Stent System

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

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
    2015-06-22
  • Event Date Posted
    2015-06-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150622c.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: orsiro sirolimus eluting coronary stent system medical device manufacturer, biotronik, has issued a medical device safety alert concerning its orsiro sirolimus eluting coronary stent system [reference numbers: 391240 & 391241; lot numbers: 02152670, 02152671, 02152672, 02152673]. according to the manufacturer, four lots of the orsiro stent system had been wrongly labeled. the labeled diameter does not reflect the actual diameter of the packed product. the use of a product from the affected lots may result in vessel injury and/or increased procedure time. users are advised to discontinue any further use of the affected products. according to the local supplier, only one lot [reference number: 391241 and lot number: 02152673] of the affected products had been imported and distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 june 2015.

Device

Eluting Coronary Stent System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Orsiro Sirolimus Eluting Coronary Stent System
  • Manufacturer
    Biotronik

Manufacturer

Biotronik
  • Manufacturer Parent Company (2017)
    Ms Holding Ii Se
  • Manufacturer comment
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    DH