Events

Safety Alert for Products Affected: (1). ABSORB BIORESORBABLE VASCULAR SCAFFOLD - Registration: 80146501896; Risk class IV - Models: 1012462-08; 1012462-12; 1012462-18; 1012462-23; 1012462-28; 1012463-08; 1012463-12; 1012463-18; 1012463-23; 1012463-28; 1012464-12; 1012464-18; 1012464-23; 1012464-28 //// (2). ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD - Registration: 80146501969 - - Risk Class IV (Maximum Risk) - Models: 1234250-08; 1234250-12; 1234250-18 1234250-23; 1234250-28; 1234300-08 1234300-12; 1234300-18; 1234300-23 1234300-28; 1234350-12; 1234350-18 1234350-23; 1234350-28

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios do Brasil Ltda.; Abbott Cardiovascular.

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
    1767
  • Date
    2015-12-02
  • 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 the company, the objective of the communiqué is to present techniques that facilitate the achievement of optimized clinical results and reduce the possibility of thrombosis and restenosis. The AV will update the Instructions for Use (UI) with this information. Until IU is available, this release aims to present the techniques mentioned. Company Update on 07/22/2016: Following the approval of Absorb GT1 ™ Bioresorbable Vascular Scaffold (BVS) System in the United States, Abbott Vascular is voluntarily updating the Prior Field Safety Notice that was submitted on 07 / Dec / 2015 . This Field Safety Warning update is for all sizes of Absorb ™ BVS and Absorb GT1 ™ BVS. The update consists of global alignment of the Absorb and Absorb GT1 indications. Date of identification of the problem by the company: 12/02/2015 - Notification date for Anvisa: 12/2/2015 - At the time, Alert 1767 was published by Anvisa's SISTEC system - Abbott Laboratories do Brasil Ltda. has notified ANVISA of a field safety warning related to Absorb Bioresorbable Vascular Scaffold to guide health care providers about the importance of following the optimized implantation technique. - UPDATES: • 22/07/2016 - Abbott Laboratories do Brasil Ltda. It has notified ANVISA of a revision in the Field Safety Notice to review the indication to restrict the use of the product in vessels with a diameter of <2.5 mm. • 12/07/2017 - According to information provided, the registrant has already informed all its clients about the use of Absorb / Absorb GT1 Bioresorbable Vascular Scaffold and the Field Safety Notification in Dec / 2015 and July / 2016 . The company that holds the affected product registration is responsible for timely contacting its customers in order to ensure the effectiveness of the ongoing Field Action.
  • Reason
    Abbott vascular published the results of absorb iii, a clinical trial comparing the safety and efficacy of absorb ™ bvs to xience®, metal eluting stent with drug elution. the findings of an analysis of absorb iii data and other published data have identified an impact on clinical outcomes after changes in the techniques of the procedure. it is expected that the implementation of these techniques will facilitate the achievement of optimized clinical results and reduce the possibility of thrombosis.
  • Action
    The company has developed a Safety Notice linking the results of a clinical trial, ABSORB III, which compared the safety and efficacy of Absorb BVS to XIENCE. It is strongly recommended that medical users follow the instructions for use contained in the Safety Notice. (SEE ATTACHED).

Device

Products Affected: (1). ABSORB BIORESORBABLE VASCULAR SCAFFOLD - Registration: 80146501896; Risk ...

Manufacturer

Abbott Laboratórios do Brasil Ltda.; Abbott Cardiovascular
  • 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