Events

Safety Alert for Coronary Stents CYPHER Sirolimus-Eluting

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Cordis Corp A Johnson 403 Johnson Co.

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
    749
  • Date
    2003-10-30
  • 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
    BRAZIL - October 30, 2003 - ANVISA. Although, to date, no events related to said product have been communicated to Brazil, and in order to ensure that the health products are safe and effective, ANVISA, through security measures, through the Unit requested the JOHNSON & JOHNSON PROFESSIONALS LTD - BRAZIL which measures the company will adopt in the domestic market, in light of the events reported in the international market, mainly in the United States. BRASIL - NOVEMBER 05, 2003 - JOHNSON & JOHNSON PRODUCTOS PROFISSIONAIS LTDA - BRASIL, in compliance with ANVISA / UTVIG letter no. 90/2003, dated October 30, 2003, states: "That there was no claim or notification of adverse effect relative to the use of the Cypher Coronary stent "
  • Reason
    Fda has issued an fda notice to inform health professionals of reactions of subacute thrombosis (sat) and hypersensitivity with the use of the cypher cordis coronary stent. on october 20, 2003, the fda received more than 290 reports (260 us and 25 outside the us) involving subacute thromboses (sat) associated with the cypher stent. over 60 reports of sats were associated with patient death and the remaining reports were associated with injuries / injuries in the patient who required medical or surgical intervention. the fda has received more than 50 reports, including some deaths, that cordis considers possible hypersensitivity reactions. the symptoms reported include: pain, hives, respiratory changes, fever, itching, and changes in blood pressure.
  • Action
    FDA reports that so far they have not identified the cause (s) of the events so they can not make specific recommendations. It further informs that as soon as they obtain more information regarding the mechanisms of these events, they will disclose the information. FDA encourages you to follow the instructions for use. For more information on the Cypher stent, see the Instructions for Use at http://www.fda.gov/cdrh/pdf3/P020026c.pdf or the patient guide at http://www.fda.gov/cdrh/pdf3/ P020026d.pdf. For more information on the drug sirolimus, which is marketed as Rapamune, see Medical Instructions for Use at www.fda.gov/cder/foi/label/2003/021083s006lbl.pdf, or see FDA page: http: // www. fda.gov/cdrh/safety/cypher.html

Device

Coronary Stents CYPHER Sirolimus-Eluting

Manufacturer

Cordis Corp A Johnson 403 Johnson Co
  • Source
    ANVSANVISA