FDA Warns that Use of the Stryker Wingspan Stent System Outside of Approved Indications Leads to an Increased Risk of Stroke or Death
- Food and Drug Administration
- Critical Access Hospitals,
The US Food and Drug Administration (FDA) has issued a safety communication to provide the results from the mandated postmarket surveillance study (Section 522 study) entitled "Wingspan StEnt System PostmArket SurVEillance (WEAVE)" to inform health care providers and patients that a significantly higher incidence of stroke or death occurred within 72 hours of the procedure when the Wingspan was used in patients outside of the FDA-approved indications for use.
Stryker’s Wingspan Stent System (W…