Events

Recall of Nellix EndoVascular Aneurysm Sealing System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by AA-Med 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-01390-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-11-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01390-1
  • 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
    The pre-market clinical trials & post-market surveillance data showed that the rates for device migration, endoleak, and/or aneurysm enlargement were higher than anticipated. a root cause investigation, including consultation with physicians and review of ct scans of patients with the events was completed. based upon this, endologix is updating the instructions for use (ifu) with more detailed information regarding the indications for use, patient selection criteria & procedural best practices.Furthermore, patients exhibiting the following key anatomic elements may be at risk regardless of the nellix system version being implanted: · anatomies outside of the respective, specific criteria defined as part of the indications for use · narrow aortoiliac bifurcation not suitable for balloon-expandable stent deployment· formation of thrombus &/or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface (i.E., sealing zone).
  • Action
    The outcome of the investigation resulted in the refined indication for use, patient selection criteria, and procedural best practices as outlined in the customer letter. Endologix representative will provide additional training on the key IFU changes to enable Physicians and their team to become familiar with the updated IFU prior to formal availability. Physicians are notified that all patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular implant. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular implant) should receive enhanced follow-up. Additional endovascular intervention or conversion to standard open surgical repair should be considered for patients continuing to experience enlarging aneurysms, implant displacement, and/or significant endoleaks during post-operative follow up. This action has been closed-out on 17/05/2017.

Device

Nellix EndoVascular Aneurysm Sealing System
  • Model / Serial
    Nellix EndoVascular Aneurysm Sealing SystemARTG Numbers: 234418 , 235301, 271832, 271833
  • Manufacturer
    AA-Med Pty Ltd

Manufacturer

AA-Med Pty Ltd
  • Source
    DHTGA