Events

Safety Alert for Trade name: Core Valve Evolut A / R Transcatheter Valve R //. Technical Name: Cardiac Valve Prosthesis //. ANVISA registration number: 10339190629 //. Risk class: IV (Maximum Risk) //. Affected Model (s) and Batch (s) / Serial Number (s) Affected. Attached distribution list

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
    1962
  • Date
    2016-08-03
  • 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 recommendations below are intended for physicians / health professionals, and further details of the guidelines can be found in the FA729 Customer Letter: 1) Patient anatomy considerations: Physicians should consider whether complex anatomical configurations, including combinations of two or more traits below, raise the risk of vascular trauma. 2) Procedure Use: During the advancement of the introduction system, enlarge the images sufficiently to allow the tip of the capsule to be viewed relative to the vasculature of the patient. If you observe the tip of the infeed folding system in a different direction from the infeed cap, do not force the infeed. Instead, retract the introduction system to a straight part of the descending aorta, reorient it by rotating the 90 degree introductory system and restart the passage very carefully. 3) Use of the procedure: If significant resistance is encountered during the advance of the introduction system, do not force the passage. Use magnification of fluoroscopy to evaluate the vasculature. If no damage is identified, retract the delivery system to a straight portion of the descending aorta and consider the actions outlined in the FA729 Customer Letter. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    Possible vascular trauma using medtronic's enveo ™ r catheter entry system (dcs). although reports of vascular trauma received by medtronic were not frequent (0.136%, 39 events), they contained serious results, including death of patients (19 events). the field action, as described in the enclosed customer letter fa729, encompasses two distinct models of the core valve evolut r aortic transcatheter valve, these models are: 1. enveor-l; and 2.Enveor-lc. however in brazil, medtronic holds the registration and commercializes the model enveor-l (registration no.: 10339190629).
  • Action
    Field Action No. FA729 triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA. The Field Action is an update of the instructions for use. Recommendations for Physicians / Health Practitioners: 1) Patient Anatomy Considerations: Physicians should consider whether complex anatomical configurations, including combinations of two or more traits below, increase the risk of vascular trauma. 2) Procedure Use: During the advancement of the introduction system, enlarge the images sufficiently to allow the tip of the capsule to be viewed relative to the vasculature of the patient. If you observe the tip of the infeed folding system in a different direction from the infeed cap, do not force the infeed. Instead, retract the introduction system to a straight part of the descending aorta, reorient it by rotating the 90 degree introductory system and restart the passage very carefully. 3) Use of the procedure: If significant resistance is encountered during the advance of the introduction system, do not force the passage. Use magnification of fluoroscopy to evaluate the vasculature. If no damage is identified, retract the delivery system to a straight portion of the descending aorta and consider the actions outlined in the FA729 Customer Letter.

Device

Trade name: Core Valve Evolut A / R Transcatheter Valve R //. Technical Name: Cardiac Valve Prost...

Manufacturer

MEDTRONIC COMERCIAL LTDA
  • Source
    ANVSANVISA