Events

Safety Alert for INSTRUMENTAL FOR HEART VALVES, Model Measuring Device / Dimensioner - models: 7305UX / 73050OD. Record Record Number 10339190370

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medtronic Comercial Ltda.

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
  • Event ID
    1349
  • Date
    2014-01-08
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    The company reports that the above-normal transvalvular gradients (> 25 mmHg) of Mosaic Aortic Bioprosthesis occurred at a rate of 0.33 percent (3.3 reports for every 1,000 aortic implants). A subgroup of these valves was explanted within five years of implantation at a general occurrence rate of 0.1 percent (1 explant for every 1,000 aortic implants). Medtronic has determined that the practice of significant oversizing may lead to cases of transvalvular gradients that are higher than expected. Specifically, considerable oversizing, or implanting a valve significantly larger than the native aortic annulus, may result in alteration of the normal movement of the leaflet since the blood flowing through the native ring may not correspond correctly to the size and / or shape of the flow of the Mosaic Aortic Bioprosthesis. In addition, Medtronic concluded that the current Mosaic Aortic Bioprosthesis sizing table (iEOA) and the Shutters / Dimensioners may in some cases contribute to the selection of a larger Mosaic Aortic Bioprosthesis the ideal. #### (10/03/2014): The field action was finalized by the company on 04/08/2014.
  • Reason
    Medtronic received unusual reports of overvalued transvalvular gradients occurring after implantation, not associated with the mosaic mitral ™ bioprosthesis (model 310).
  • Action
    Medtronic recommends that surgeons remain vigilant in selecting the appropriate size of Mosaic Aortic Bioprostheses. Adoption of the Mosaic Aortic Bioprosthesis sizing chart (iEOA table) and the updated Mosaic Suture / Sizer dimensions will ensure the selection of the ideal aortic valve size. Medtronic is not making any specific recommendations related to the treatment of the patient. Surgeons and cardiologists should continue to follow their implanted patients in accordance with their usual practices and published instructions. The Medtronic Local Representative will contact you regarding the receipt of a set of Mosaic Aortic Shutters / Dimensioners and the new sizing chart as well as for new training.

Device

INSTRUMENTAL FOR HEART VALVES, Model Measuring Device / Dimensioner - models: 7305UX / 73050OD. R...

Manufacturer

Medtronic Comercial Ltda
  • 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
    ANVSANVISA