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

PUBLISHED: Apr 25, 2019
Relevant to: Critical Access Hospitals, 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 (Wingspan) is used to open narrowed arteries in the brain of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. Wingspan is FDA-approved only for patients who are between 22 and 80 years old AND meet ALL the following criteria:

  • who have had two or more strokes despite aggressive medical management;
  • whose most recent stroke occurred more than seven days prior to planned treatment with Wingspan;
  • who have 70-99 percent stenosis due to atherosclerosis of the intracranial artery related to the recurrent strokes; and
  • who have made good recovery from the previous stroke and have a modified Rankin Scale score of three or less prior to Wingspan treatment. The Rankin scale is used to measure the degree of disability at the time of evaluation. Lower scores indicate less or no disability.

Wingspan is approved through the Humanitarian Device Exemption (HDE) regulatory pathway. Humanitarian Use Devices (HUD) eligible for the HDE regulatory pathway are intended to treat or diagnose a disease or condition that affects not more than 8,000 people in the United States per year. Generally, a patient may be treated with Wingspan only if the treating physician has received Institutional Review Board (IRB) approval to use the Wingspan at the clinical site.

Recommendations for Health Care Providers:

  • Use Wingspan only in patients who are between 22 and 80 years old AND who meet ALL the following criteria:
  • who have had two or more strokes despite aggressive medical management;
  • whose most recent stroke occurred more than seven days prior to planned treatment with Wingspan;
  • who have 70-99 percent stenosis due to atherosclerosis of the intracranial artery related to the recurrent strokes; and
  • who have made good recovery from previous stroke and have a modified Rankin Scale score of three or less prior to Wingspan treatment.
  • Be aware that the use of Wingspan in patients who do not meet the FDA-approved indications for use criteria significantly increases the risk of stroke or death.
  • Consider patient selection carefully after reviewing the approved labeling, including the indications for use, contraindications, warnings, and precautions.
  • When using Wingspan, treat only the vessel that caused the stroke.
  • Be aware that Wingspan is only approved by the FDA as an HDE device for a very specific group of patients.
    • Generally, a patient may be treated with Wingspan only if the treating physician has received Institutional Review Board (IRB) approval to use the Wingspan at the clinical site.
  • Only use Wingspan if you have been trained to perform neurointerventional procedures as well as properly trained and proctored by the manufacturer to use the device.
  • If you plan to use the Wingspan device at your facility, share this communication with appropriate hospital staff, applicable Institutional Review Boards, and credentialing committees to ensure the clinical community is aware of the risk of stroke or death when Wingspan is used outside the FDA-approved indications for use.
  • If a patient experiences a complication following treatment with Wingspan, please file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

The safety communication also includes recommendations for patients and caregivers.

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