Safety Alert for STENT WINGSPAN - Record 80005430258 - Ref.90741728-FA - PRODUCT NUMBER: M003WE0250090; M003WE0250150; M003WE0250200; M003WE0300090; M003WE0300150; M003WE0300200; M003WE0350090; M003WE0350150; M003WE0350200; M003WE0400090; M003WE0400150; M003WE0400200; M003WE0450090; M003WE0450150; M003WE0450200 - ALL LOTS.

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.

THIS IS NOT A PROCUREMENT OF THE PRODUCT. Stryker acquired the Boston Scientific Neurovascular business in early 2011. Currently, Boston Scientific continues to manufacture and label these devices on behalf of Stryker. In September 2011 preliminary results from the Stenting and Aggressive Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPIRS - Stenting and Active Medical Treatment for Preventing Recurrent Stroke in Intracranial Stenosis) were published in the New England Journal of Medicine New England]. Preliminary results from the SAMMPRIS study demonstrated that the use of active medical therapy plus angioplasty and stenting (PTAS) to prevent stroke in patients at high risk for ADHD was no better than active medical therapy per se. While this is the standard of care for initial treatment of patients with ICAD, the company does not state in the instructions for use of the Wingspan® and Gateway Balloon Catheter® PTA Patient Instructions that patients should be refractory to medical therapy prior to using the Wingspan Stent . Revised Intended Use / Indications for Use of the Wingspan Stent as follows: Intended Use / Indications for Use The Wingspan® Stent System and Gateway Balloon PTA ™ indicated for use in improving the diameter of the cerebral artery lumen in patients with atherosclerotic lesion intracranial, refractory to medical therapy, in stenosis of intracranial vessels> 50%, accessible by the system. The change was duly petitioned by the registration area. #### UPDATE: 04/03/2012 - The company sends a list of customers contacted and the order file for changing the instructions for use, not yet analyzed by the competent technical area. of the instructions of use duly approved and published in DOU - Gemat memo 504/2012. #### COMPLETED.