Events

Recall of MitraClip System (Product Number # MSK02ST) containing the Clip Delivery System (Part number # CDS02ST) and the Steerable Guide Catheter (Part number # SGC01ST)(Used for reconstruction of the insufficient mitral valve through tissue approximation)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Abbott Vascular Division of Abbott Australasia Pty Ltd.

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
    RC-2016-RN-00139-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-02-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00139-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Abbott vascular has recently received nine reports of cases on clip delivery system devices that contain the one-way actuator knob (lot number 50714u1 and greater) where a user attempted implanting a mitraclip, but the clip could not be detached from the delivery system due to a mandrel fracture. these cases resulted in surgical interventions and, in one case; the patient expired post-operatively due to severe comorbidities.The mandrel is an internal component of the clip delivery system that is integral to clip function and deployment. abbott vascular’s investigation determined that a mandrel fracture may occur if tension is present on the mandrel when turning the actuator knob to deploy the clip. tension is present if the arm positioner is on the “closed” side of neutral, as opposed to being in the neutral position during clip deployment.
  • Action
    While the 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, Abbott Vascular 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. The customer letter identifies what is changing in the IFU and explains the importance in eliminating tension during the delivery of the clip. Abbott Vascular is continuing to investigate the issue and working with the TGA to ascertain if any further actions need to be undertaken. This action has been closed-out on 17/05/2017.

Device

MitraClip System (Product Number # MSK02ST) containing the Clip Delivery System (Part number # CD...
  • Model / Serial
    MitraClip System (Product Number # MSK02ST) containing the Clip Delivery System (Part number # CDS02ST) and the Steerable Guide Catheter (Part number # SGC01ST)(Used for reconstruction of the insufficient mitral valve through tissue approximation)Lot numbers: 50714U1 and higherARTG numbers:177709 and 189720
  • Manufacturer
    Abbott Vascular Division of Abbott Australasia Pty Ltd

Manufacturer

Abbott Vascular Division of Abbott Australasia Pty Ltd
  • 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
    DHTGA