Use of the Stryker Wingspan Stent System Outside of the Approved Indications Leads to an Increased Risk of Stroke or Death

Today, the U.S. Food and Drug Administration (FDA) is providing results from the mandated postmarket surveillance (Section 522) study entitled “Wingspan StEnt System PostmArket SurVEillance (WEAVE)” and issuing a Safety Communication to inform health care providers, patients, and Institutional Review Boards that a significantly higher incidence of stroke or death occurred within 72 hours of the procedure when Stryker’s Wingspan Stent System (Wingspan) was used outside the FDA-approved indications for use. Wingspan is used to open narrowed arteries in the brain of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. Wingspan is approved through the Humanitarian Device Exemption (HDE) regulatory pathway as a Humanitarian Use Device (HUD) only for the specific group of patients outlined in the FDA-approved indications for use criteria in the device’s labeling. The FDA recommends health care providers consider patient selection carefully after reviewing the approved labeling including the indications for use, contraindications, warnings, and precautions.

Read the Safety Communication The FDA will continue to work with Stryker to revise the Wingspan labeling to ensure health care providers are aware of the increased risk of stroke and death when used outside the FDA-approved indications for use. Questions? If you have questions about this Safety Communication, contact the Division of Industry and Consumer Education.