Events

Safety Alert for Five products affected by the Field Action. 1. PIPELINE EMBOLIZING DEVICE - Registration 10349000471 - Technical Name: ANEURISMA IMPLANT - Risk Class IV ;. 2. ALLIGATOR RECOVERY DEVICE - Registration 10349000457 - Technical Name: DEVICES - Risk Class IV ;. 3. HYDROFILIC GUIDE X-CELERATOR - Registration 10349000313 - Technical Name: FIO CARDIOVASCULAR GUIDE - Risk Class II ;. 4. ULTRAFLOW HPC FLOW ORIENTED MICROCATETER - Record 10349000461 - Technical Name: INTRAVASCULAR MICROPHYDRUS CATETER - Risk Class IV ;. 5. MARATHON MICRO CATHETER FLOW DIRECTED - Record 10349000478 - Technical Name: INTRAVASCULAR MICROPHEPER CATHETER - Risk Class IV ;. Affected lots: Products manufactured between August 2014 and September 2016

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by AUTO SUTURE DO BRASIL LTDA; Micro Therapeutics, Inc. - d/b/a ev3 Neurovascular.

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
    2012
  • Date
    2016-10-05
  • 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
    Recommendations for users and patients: For affected products that have been used, no action is necessary and patients should continue to be monitored in accordance with the patient's protocol of conduct. If the products affected by the recall have not been used, the customer must immediately take the following actions: 1. Remove and quarantine all unaffected products in inventory. 2. Return potentially affected products to Medtronic. #### UPDATED ON 7/24/2017, the company submitted the field action completion report proving the sending of the safety notice to the client and collection of the equipment informed.
  • Reason
    Medtronic has identified a potential problem with a specific batch number group of medtronic neurovascular products, as noted below, where the ptfe (polytetrafluoroethylene) coating could delaminate and separate from the shaft. as a result, we are recalling the products listed in appendix 1 of the attached letter to the customer. this problem affects batches of the following medtronic products manufactured between august 2014 and september 2016: 1. pipeline ™ embolization device 2. alligator ™ recovery device 3. marathon flow directed micro catheter (with chuck) 4. flow oriented microcateter ultraflow hpc (with chuck) 5. xcelerator ™ hydrophilic guidewire.
  • Action
    Field Action Code FA 740 triggered under the responsibility of the company AUTO SUTURE DO BRASIL LTDA. Company is performing the collection of products that have not been used for later return to the manufacturer.

Device

Five products affected by the Field Action. 1. PIPELINE EMBOLIZING DEVICE - Registration 10349000...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; Micro Therapeutics, Inc. - d/b/a ev3 Neurovascular
  • 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