Events

Recall of Mosaic Porcine Aortic Bioprosthesis Model 305 and Medtronic Aortic Obturators/Sizers and iOEA Charts Hazard Alert - MosaicPorcine Aortic Bioprosthesis Model 305 All sizes and configurations ie, Standard and Ultra Recall - Medtronic Aortic Obturators/Sizers and iOEA -indexed Effective Orifice Area Charts

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic 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-2014-RN-00015-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-01-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00015-1
  • 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 current mosaic aortic bioprosthesis sizing chart and obturators/sizers may contribute in some cases to the selection of a larger than optimal mosaic aortic bioprosthesis. medtronic has determined that the practice of substantial oversizing can lead to the reported cases of higher-than-expected transvalvular gradients post implantation. specifically, considerable oversizing, or implanting a valve substantially larger than the native aortic annulus, may result in the alteration of normal leaflet movement as blood flowing through the native annulus may not properly match the size and/or shape of the inflow of the mosaic aortic bioprosthesis. the higher-than-expected transvalvular gradients (> 25 mmhg) have occurred at a rate of 0.33 percent (3.3 reports per 1000 aortic implants). a subset of these valves were explanted within five years of implantation at an overall occurrence rate of 0.1 percent (1 explant per 1000 aortic implants).
  • Action
    Medtronic is not making any specific patient management recommendations for the patients implanted with the Medtronic Mosaic Aortic Bioprosthesis. Surgeons and cardiologists should continue to follow their patients per their usual practice and in accordance with published guidelines. Medtronic has updated the iEOA Mosaic Aortic Bioprosthesis sizing chart and also, modified the current Mosaic Obturators/Sizers to align with the updated sizing chart. The IFU for the modified Mosaic Obturators/Sizers has been updated to include the new sizing chart (iEOA chart). Medtronic recommends surgeons continue to remain diligent in selecting the appropriate size of Mosaic Aortic Bioprosthesis. Adoption of the updated Mosaic Aortic Bioprosthesis sizing chart (iEOA chart) and Mosaic Obturators/Sizers will facilitate optimal aortic valve size selection. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-bioprosthesis-140128.htm .

Device

Mosaic Porcine Aortic Bioprosthesis Model 305 and Medtronic Aortic Obturators/Sizers and iOEA Cha...
  • Model / Serial
    Mosaic Porcine Aortic Bioprosthesis Model 305 and Medtronic Aortic Obturators/Sizers and iOEA Charts Hazard Alert - MosaicPorcine Aortic Bioprosthesis Model 305 All sizes and configurations ie, Standard and UltraARTG 145761Recall - Medtronic Aortic Obturators/Sizers and iOEA -indexed Effective Orifice Area Charts Model Numbers: 7305, 7305OD, 7305UXARTG 98977
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA