Events

Safety Alert for Absorb GT1 Bioresorbable Vascular Scaffold (BVS)

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
    2017-11-01
  • Event Date Posted
    2017-11-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171101.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 gt1 bioresorbable vascular scaffold (bvs) the united states food and drug administration (fda) has issued an alert to health care providers to inform the health care community that interim study results through three years from the pivotal clinical trial (absorb iii) continue to show an increased rate of major adverse cardiac events and bvs scaffold thrombosis in patients receiving the absorb gt1 bioresorbable vascular scaffold (bvs), when compared to patients treated with the approved metallic xience drug-eluting stent. the fda was made aware that the manufacturer has stopped global sales of the absorb gt1 bioresorbable vascular scaffold as of 14 september 2017. although health care providers with available inventory may continue to implant the bvs, they should carefully consider its safety and effectiveness and only use it if they believe it is in the best interest of their patients. while the manufacturer has discontinued sales of bvs, they will continue to monitor patients currently enrolled in the absorb iii and absorb iv us clinical studies through five years following bvs implantation. patients enrolled in these studies will be followed through standard practice and care after five years. the fda provided the following recommendations to health care providers: follow the instructions for target heart vessel selection (e.G., avoiding bvs use in small heart vessels) and optimal device implantation that are included in the bvs physician labeling. advise patients experiencing any new cardiac symptoms such as irregular heartbeats, chest pain, or shortness of breath to seek clinical care. for more information about risks associated with the bvs, refer to the bvs physician labeling. advise bvs patients to follow the recommendations for dual antiplatelet therapy (dapt) prescribed by their health care providers. for details, please refer to the fda websites: https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm547256.Htm https://www.Fda.Gov/medicaldevices/safety/letterstohealthcareproviders/ucm582728.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 november 2017.

Device

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