Events

Safety Alert for HeartMate 3 Left Ventricular Assist System

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
    2018-04-12
  • Event Date Posted
    2018-04-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180412a.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: heartmate 3 left ventricular assist system medical device manufacturer, abbott, has issued a medical device safety alert concerning its heartmate 3 (hm3) left ventricular assist system [catalog number: 106524int – hm3 lvas kit]. the manufacturer has received reports of outflow graft twist occlusions in the heartmate 3 left ventricular assist system. as a result, patients whose devices experience these outflow graft occlusions will experience a persistent low flow alarm. according to the manufacturer, there are 32 total reports associated with outflow graft twisting in the hm3 device, an occurrence of 0.72 percent based on 4,467 implants worldwide outflow graft twists can result in serious adverse events such as hemodynamic compromise, thrombus, and death. postoperative twisting and occlusion of the hm3 outflow graft may result in the need for surgical intervention following the original implant procedure. the affected users are advised to take the following actions: during implant, when attaching the outflow graft to the pump cover, a clicking sound will be heard as the screw ring is tightened. continue turning the screw ring clockwise until it comes to a complete stop and stops clicking for a firm hand tightened connection. if a low flow alarm persists at any time following implant, and other potential causes such as hypertension, low preload, right-heart failure and inflow occlusion have been considered for cause, a computed tomography angiography should be taken to identify the possibility of an outflow graft twist occlusion. in the event surgical repair of the outflow graft is needed due to a twist occlusion, the outflow graft bend relief should be reattached in its original state or repaired to prevent further kinking or occlusion of the graft. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 april 2018.

Device

HeartMate 3 Left Ventricular Assist System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: "HeartMate 3 Left Ventricular Assist System"
  • 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