FDA Issues Warning of Stroke, Death Risk With Non-approved Wingspan Stent Use

The Stryker Wingspan Stent System is designed to open up narrow arteries in the brains of individuals who have experienced repeated strokes. When it is used on patients who do not meet the usage criteria outlined by the FDA, however, it can have life-threatening or fatal consequences.

According to a warning released by the FDA on April 25, 2019, new study data “reinforces that the risk of stroke or death is higher when this device is used in patient populations outside of the FDA-approved indications for use.” In addition to emphasizing the importance of complying with patient selection criteria guidelines, the FDA warned health care providers and patients to only use the Wingspan device for reasons listed on its labeling.

The use of Wingspan is only FDA-approved for patients who meet all of the following criteria:

• Between the ages of 22 and 80 years old
• Most recent stroke occurred more than seven days before Wingspan treatment
• Have 70-99 percent stenosis due to atherosclerosis of the intracranial artery that is related to the repetitive strokes
• Have previously recovered well from stroke
• Have a modified Rankin Scale, which measures the degree of disability, at a score of three or below (indicating low or no disability)

This warning comes after the completion of a study that examined 72 hour procedure outcomes of 198 patients who were treated with the Wingspan Stent System. Out of these patients, 46 of them (or just over 23 percent) did not meet the criteria for usage. The results were drastic: 23.9 percent of the patients who did not meet the FDA-approved criteria experienced stroke or death, while only 2.6 percent of patients who met the criteria did. Above all else, these results make it clear that doctors who negligently ignore the FDA’s criteria are putting the lives of their patients in critical danger.

Our law firm of Childers, Schlueter, & Smith is well-versed in drug and medical device litigation and might be able to help you or a family member who is suffering due to complications caused by a defective or dangerous device. If you have questions, please give us a call at 1-800-641-0098. All initial inquiries are free of charge and without obligation.