Events

Safety Alert for HeartMate II® Left Ventricular Assist System

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

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
    2012-02-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120228a.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
    Field safety notice: thoratec heartmate ii® left ventricular assist system. medical device manufacturer, thoratec corporation, has issued a field safety notice on the use of thoratec heartmate ii® left ventricular assist system. the affected devices included all lot numbers of the heartmate ii® left ventricular assist system sealed outflow graft short bend relief (catalog no. 104692) and thoratec heartmate ii sealed outflow graft (catalog no. 103393). all serial numbers of the thoratec heartmate ii implant kit with sealed grafts (catalog nos. 104911 and 104912). the manufacturer is aware of a recent trend in reports of disconnection of the bend relief from the sealed outflow graft, a component of the heartmate ii lvas. the bend relief is a tube of eptfe surrounding the outflow graft proximal to the pump that is designed to prevent kinking of the outflow graft. disconnection of bend relief from the sealed outflow graft may potentially lead to outflow graft kinking and/or graft abrasion. symptoms of outflow graft kinking included low pump flow, hemolysis, bleeding, and fluctuations in pump flow, speed and/or power, or worsening symptoms of heart failure. graft abrasion may lead to serious bleeding. so far, the manufacturer has identified 29 reports of disconnected bend relief. five of the reports had symptoms of outflow graft kinking with one of them died of multi-organ failure. however, it is not clear as to what extent the disconnected outflow graft bend relief may have caused or contributed to this patient’s condition. besides, there were also three reports of serious bleeding that might be due to graft abrasion. according to the local supplier, the affected device has been distributed in hong kong but there were no similar adverse events reported here. if you are in possession of the product, please contact your supplier for necessary actions.

Device

HeartMate II® Left Ventricular Assist System

Manufacturer

Thoratec Corporation
  • 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