Events

Safety Alert for IN.PACT Amphirion Drug-Eluting Balloon

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

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
    2013-11-11
  • Event Date Posted
    2013-11-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131111a.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: medtronic in.Pact amphirion drug-eluting balloon the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning in.Pact amphirion drug-eluting balloon (deb) manufactured by medtronic, inc. based on data from clinical study, the in.Pact amphirion deb did not meet its safety and efficacy endpoints relative to the percutaneous transluminal angioplasty control. the study also identified a potential safety signal given a trend towards an increased rate of major amputations in the deb study arm. the manufacturer is advising hospitals to quarantine all units of the in.Pact amphirion deb that remain in their inventory. according to the local supplier, the affected products were distributed in hong kong. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01153-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 november 2013.

Device

IN.PACT Amphirion Drug-Eluting Balloon
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic IN.PACT Amphirion Drug-Eluting Balloon
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH