Events

Safety Alert for Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS Systems

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

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
    2015-12-07
  • Event Date Posted
    2015-12-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151207a.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 vascular absorb bioresorbable vascular scaffold (bvs) and absorb gt1 bvs systems medical device manufacturer, abbott, has issued a medical device safety alert concerning absorb bioresorbable vascular scaffold (bvs) and absorb gt1 bvs systems. the manufacturer has recently published the results of absorb iii, a prospective randomized controlled clinical trial that compared the safety and effectiveness of the affected products to their metallic drug-eluting stent, xience. learning from an analysis of the absorb iii data and other published data have identified an impact on clinical outcomes following changes to procedural techniques. implementation of the techniques is expected to facilitate optimal clinical outcome and reduced the possibility of thrombosis. according to the manufacturer, there is no need to return the affect products and patients who have had successfully implanted of the scaffolds are not affected by this action. the manufacturer is issuing field safety notice to inform the customers about the key changes and will update the instructions for use. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 december 2015.

Device

Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS Systems
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Vascular Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS Systems
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • 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