Events

Recall of Evalve Mitraclip Clip Delivery System (CDS)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Evalve Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    19733
  • Event Initiated Date
    2016-02-05
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Abbott Vascular Division of Abbott Laboratories (NZ) Ltd, Ground Floor, Building D, 4 Pacific Rise, Mount Wellington, Auckland 1060
  • Reason
    Manufacturer has recently received reports of cases in clip delivery system devices that contain the one-way actuator knob where a user attempted implanting a mitralclip but the clip could not be detached from the delivery system due to a mandrel fracture. these cases resulted in severe surgical interventions and in one case the patient died post-operatively due to severe comorbidities., current instructions for use (ifu) require the arm positioner to be in a neutral position prior to turning the actuator knob to deploy the clip; manufacturerr is revising the mitraclip ifu clip deployment sequence to provide additional assurance that tension is completely eliminated prior to deploying the clip. abbott vascular will train all mitraclip implanters on the revised instructions., note : currently, there are no mitraclip systems in new zealand.
  • Action
    Manufacturer to issue advice regarding use

Device

Evalve Mitraclip Clip Delivery System (CDS)

Manufacturer

Evalve Inc
  • 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
    NZMMDSA