Events

Safety Alert for EVEROLIMUS ELUTING CORONARY STENT. ANVISA Register: 80146501423. Model XIENCE V. Batch Affected: 8040841.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Aboott Laboratórios do Brasil 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
    962
  • Date
    2009-04-08
  • 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
    According to Abbott Ltda, the problem is noticeable during the preparation of the material - hence, therefore, of the stent implantation in the patient - and does not affect the stent itself. The reason for the recall was the receipt of three case reports by Abbott regarding the problem in the distal rod of the product. The Technovigilance Unit is following up on this case.
  • Reason
    The balloon of the distal tip of the catheter, responsible for the implantation of the stent, may not inflate until the end. this problem may compromise the implantation of the stent in the patient.
  • Action
    The holder of the registration of the product in Brazil has already begun the communication to the customers involved and the collection of the affected products in the market. Users are advised to: (1) Check for affected batch products in stock; (2) Collect affected products and segregate them, identifying them properly to avoid misuse; (3) Contact the product registration holder in Brazil.

Device

EVEROLIMUS ELUTING CORONARY STENT. ANVISA Register: 80146501423. Model XIENCE V. Batch Affected: ...

Manufacturer

Aboott Laboratórios do Brasil Ltda.
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA