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 의 안전성 경고

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.

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.