May 1, 2019
FDA Advises of Increased Adverse Outcomes With Off-Label Use of Stryker's Wingspan
April 25, 2019—The FDA issued a safety communication for the Wingspan stent system (Stryker) advising that results from the FDA-mandated WEAVE postmarket surveillance study demonstrated a significantly higher incidence of stroke or death within 72 hours of the procedure when the Wingspan was used in patients outside of the FDA-approved indications for use.
The Wingspan stent system is used to open narrowed arteries in the brain of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. The device was approved under an FDA humanitarian device exemption in 2005. Wingspan also received European CE Mark approval in 2005.
Results of the WEAVE postmarket surveillance study assessed the periprocedural safety of the Wingspan stent system (Stryker) for the treatment of symptomatic intracranial atherosclerotic disease were published by Michael J. Alexander, MD, et al online in Stroke (2019;50:889–894).
Wingspan is FDA-approved only for patients who are between ages 22 and 80 years and meet all the following criteria:
- Have had two or more strokes despite aggressive medical management
- Most recent stroke occurred more than 7 days before planned treatment with Wingspan
- Have 70% to 99% stenosis due to atherosclerosis of the intracranial artery related to the recurrent strokes
- Have made a good recovery from the previous stroke and have a modified Rankin Scale score ≤ 3 before Wingspan treatment
According to the FDA, the WEAVE study was designed as a prospective, single-arm, multicenter study. The study obtained Institutional Review Board approval and was conducted at 24 clinical sites in the United States to further assess the rates of stroke or death within 72 hours of the Wingspan stent placement procedure. A total of 198 patients were treated using Wingspan in the study. In summary:
- Of the 198 patients treated, 152 patients met the FDA-approved indications for use criteria, and 46 patients did not meet the approved indications for use criteria.
- There was a higher incidence of stroke or death within 72 hours of the procedure when the Wingspan was used in patients outside of the FDA-approved indications for use.
- Outcomes within 72 hours of treatment for patients meeting the indications for use (n = 152) versus patients who did not meet the indications for use (n = 46) include death (1.3% vs 4.3%); stroke without death (1.3% vs 19.6%); and total with stroke or death (2.6% vs 23.9%).
- The nine strokes in the non-indications for use group occurred in the territory of the stented artery. Seven strokes were ischemic and two strokes were hemorrhagic. Eight of the nine had modified Rankin Scale scores available at 90-day follow-up. Of these eight patients, four recovered by day 90.
In the study, treatments outside of the FDA-approved indications included: < 7 days since the last stroke (n = 4), < two qualifying strokes (n = 3), modified Rankin Scale score of 4 or 5 (n = 3), not refractory to medications (n = 1), treatment was unrelated to intracranial atherosclerosis disease (n = 1). Patients may have had more than one condition outside of the FDA-approved indications.
William Maisel, MD, Chief Medical Officer in the FDA’s Center for Devices and Radiological Health, commented in a follow-up FDA brief, “The FDA will continue to work with Stryker to revise the Wingspan labeling to ensure health care providers are aware of the increased risks of stroke or death when used outside the FDA-approved indications for use. The FDA will continue to communicate publicly if significant new information becomes available.
“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. 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. 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 reinforce 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.”
Dr. Maisel concluded, “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. 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.”