FDA Issues Stroke Risk Reminder for Improper Use of Wingspan Stent System

William Maisel, MD, MPH, chief medical officer in the FDA Center for Devices and Radiological Health

William Maisel, MD, MPH

The FDA has issued a reminder for health care professionals, warning them of the potential risk for stroke or mortality associated with the use of Stryker's Wingspan Stent System for unapproved indications.¹

This issuance was communicated with the results of the WEAVE study, conducted in follow-up to the FDA’s efforts to address safety concerns related to the device in 2012. The study ultimately showed a higher incidence of stroke or death when Wingspan was used outside of the FDA-approved indications, with risk increased by 21.3%.

The Wingspan Stent System was approved by the agency in 2005, in conjunction with the Gateway PTA Balloon Catheter, to improve cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with ≥50% stenosis that are accessible to the system.²

“For every FDA medical device approval, we carefully assess the benefits and risks of the device to ensure patients have access to devices that will positively impact their health,” said William Maisel, MD, MPH, the chief medical officer in the FDA’s Center for Devices and Radiological Health, in a statement. “This benefit-risk paradigm can shift when a device intended for a specific patient population is used in other ways. In the case of the Wingspan Stent System, the device is approved only for use in a specific subset of patients with a life-threatening neurological condition.”

According to Stryker, the system is designed for neurovascular access and gentle lesion dilation. The Wingspan Stent System features a flexible, trackable delivery system designed to facilitate access through challenging neurovascular anatomy.³

“While the device can play an important role in opening narrowed arteries in the brain of certain patients diagnosed with intracranial stenosis who are experiencing repeated strokes, new study data issued today 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,” Maisel said.

The final results of the WEAVE trial, which included 152 patients, revealed that when following on-label indications, there was only a 2.6% rate for periprocedural stroke and death with Wingspan after 72 hours, 1.7% better than the FDA target rate. In the off-label arm, the stroke or death rate after 72 hours was 23.9% (P =.0001).⁴

The trial was halted ahead of schedule, as an interim analysis demonstrated that only 4 of 152 patients experienced periprocedural stroke, bleeding, or death. At 72 hours, a total of 148 patients (97.4%) were event-free, while 2 patients (1.3%) had nonfatal strokes, and 2 patients (1.3%) died.

“As a follow up to previous alerts about this device, today the FDA is reminding health care professionals and patients to carefully follow the Wingspan device labeling, instructions for use and to consider the specific patient selection criteria for this device so they can appropriately determine whether the device is right for them,” Maisel said in his statement. “This alert is part of our ongoing commitment to device safety and our work to protect patients when we become aware of safety concerns involving medical devices.”

In the 2012 communication of Wingspan’s narrowed indication, the FDA noted that Wingspan was approved only for patients who are between 22 and 80 years old and meet all of the following criteria:

• who have had ≥2 strokes despite aggressive medical management;
• whose most recent stroke occurred more than 7 days prior to planned treatment with Wingspan;
• who have 70% to 99% stenosis due to atherosclerosis of the intracranial artery related to the recurrent strokes;
• who have made a good recovery from a previous stroke and have a modified Rankin score of ≤3 prior to Wingspan treatment.

The FDA noted that the Wingspan Stent System should not be used for the treatment of stroke with an onset of symptoms within 7 days or less of treatment or for the treatment of transient ischemic attacks.⁵

“With experienced interventionalists and proper patient selection following on-label usage guidelines, the use of the Wingspan Stent for intracranial atherosclerotic disease is safe and has low periprocedural complication rate," A Stryker spokesperson told NeurologyLive^®. "The recent FDA notification is a reminder to healthcare professionals treating intracranial atherosclerotic disease patients to follow the approved instructions for use whenever utilizing the Wingspan Stent System.”

REFERENCES

1. FDA in Brief: FDA reminds health care professionals about risks of Wingspan Stent System after study shows increased risk of stroke or death when used outside of the FDA-approved indications [press release]. Silver Springs, MD: FDA; Published April 25, 2019. fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm636673.htm. April 25, 2019.

2. Wingspan FDA label. FDA website. accessdata.fda.gov/cdrh_docs/pdf5/h050001b.pdf. Updated 2012. Accessed April 25, 2019.

3. Wingspan Stent System. Stryker website. stryker.com/us/en/neurovascular/products/wingspan-stent-system.html. Updated January 2019. Accessed April 25, 2019.

4. Alexander MJ, Zauner A, Chaloupka JC, et al. WEAVE trial. Stroke. 2019;50(4):889-894. doi: 10.1161/STROKEAHA.118.023996.

5. Narrowed Indications for Use for the Stryker Wingspan Stent System: FDA Safety Communication [press release]. Silver Springs, MD: FDA; Published January 12, 2012. wayback.archive-it.org/7993/20170722215747/https:/www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm314600.htm. Accessed April 25, 2019.