Events

Safety Alert for Zilver PTX Drug-Eluting Peripheral Stent

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

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
    2013-04-19
  • Event Date Posted
    2013-04-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130419b.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: cook ireland limited zilver ptx drug-eluting peripheral stent medical device manufacturer, cook ireland limited, has issued a field safety notice concerning zilver ptx drug-eluting peripheral stent [catalogue number: ziv6*****ptx] the manufacturer has received a number of complaint reports relating to the delivery system for the zilver ptx drug eluting stent (13 complaints with an occurrence rate of 0.043%; two occurrences were considered serious adverse events) involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section. in december 2012, the manufacturer issued a field safety notice (fsca-identifier: 2012c0005) to customers advising of the potential risk of tip/inner catheter separation, but no root cause had been established at that time. since december 2012, the manufacturer has responded to complaint reports by carrying out an in-depth investigation to better understand the root cause and the risk to patients of these tip separations. as a result of their investigation, the manufacturer is initiating a voluntary withdrawal as they have determined that there is a higher than expected potential of inner delivery catheter breakage due to inconsistencies in the catheter manufacturing process. this withdrawal is intended to address the patient risks that may be associated with this potential occurrence. this is a potential failure mode of the delivery system and does not affect the safety or efficacy of the implantable stent. previously implanted stents are not affected by this withdrawal. this notice relates only to the zilver ptx drug eluting peripheral stent delivery system. any zilver flex and other bare metal stents from cook medical are not affected. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 april 2013.

Device

Zilver PTX Drug-Eluting Peripheral Stent

Manufacturer

Cook Ireland Limited