Boston Scientific Axios Stent Recall: 3 Deaths, 167 Injuries, and Potential Lawsuits Over Deployment Failures

Patients Harmed by Stent Deployment and Expansion Failures May Have Grounds for a Medical Device Lawsuit

FDA Issues Early Alert After Stent Deployment Problems Linked to Deaths

What Parker Waichman LLP Found

• The FDA issued an early alert after reports of 167 injuries and three deaths.
• Deployment and expansion failures occur during stent delivery.
• This is the second regulatory action involving Axios products within one year.
• Off-label use does not automatically eliminate manufacturer responsibility.
• Injured patients may be eligible to file product liability claims.

Boston Scientific has instructed customers to stop using certain Axios Stent and Electrocautery Enhanced Delivery Systems following reports of serious complications, including three deaths and 167 injuries. The U.S. Food and Drug Administration published an early alert warning healthcare providers about problems related to stent deployment and expansion during procedures.

According to safety communications, the reported complications occur during the delivery and placement of the stent. These devices are designed to create a channel between organs to allow internal drainage. When functioning properly, they can replace invasive surgery with minimally invasive endoscopic techniques. When deployment fails, however, the consequences can be severe.

The three reported deaths were associated with off-label or investigational uses of the device. While Boston Scientific has stated that successfully implanted stents are not affected, problems that occur during insertion can prolong procedures, require emergency interventions, or result in life-threatening complications.

Medical device recalls involving deaths and large numbers of injuries often raise significant legal questions. Patients and families may be entitled to pursue claims if a device malfunction contributed to harm, even if the use was outside approved labeling.

What Is the Axios Stent and How Is It Used?

The Axios Stent system is commonly used in advanced endoscopic procedures. Physicians deploy it to facilitate:

• Drainage of pancreatic pseudocysts
• Treatment of walled-off pancreatic necrosis
• Gallbladder drainage in high-risk patients with acute cholecystitis
• Other gastrointestinal drainage procedures

The device allows doctors to create a direct internal connection between two structures—often the stomach and a fluid collection—so that fluid can drain safely.

In recent years, the stent has also been used in certain complex procedures such as EDGE (Endoscopic Ultrasound-Directed Transgastric ERCP) and gastrojejunostomy. Some of these applications are considered off-label or investigational.

Although off-label use is not uncommon in medicine, manufacturers must still ensure that their devices perform safely under foreseeable conditions of use. If a device has known deployment or expansion limitations, failure to warn physicians may create liability exposure.

The Reported Deployment and Expansion Failures

Boston Scientific’s safety notice states that the issues occur during stent delivery. Specifically:

• The stent may fail to deploy properly
• The first flange may not expand as intended
• Additional intervention may be required to remove the device
• The puncture site may need surgical closure

If the device cannot be properly deployed, the procedure must be extended. In some cases, physicians must remove the stent and attempt replacement with a new device. That process may increase bleeding risk, infection risk, anesthesia time, and trauma to surrounding tissue.

When deployment fails inside the gastrointestinal tract, there is also a risk of perforation, internal bleeding, sepsis, or leakage of digestive contents into the abdominal cavity. These complications can become fatal, especially in patients who are already medically fragile.

The FDA noted that this is the second regulatory action involving Axios products within a 12-month period. Previously, certain products were removed from the market because of improper expansion problems that could delay completion of procedures.

Repeated regulatory action may be examined closely in product liability litigation.

Understanding Off-Label Use and Liability

Boston Scientific indicated that the three reported deaths were associated with off-label or investigational use, including use during EDGE procedures, gastrojejunostomy, and an investigational gastroenterostomy clinical trial.

While manufacturers often point to off-label use as a defense, the legal analysis does not end there. Courts evaluate whether:

• The off-label use was reasonably foreseeable
• Marketing practices encouraged broader use
• The device was safe under conditions that physicians could reasonably encounter
• Adequate warnings were provided

If physicians routinely perform certain procedures with a device, and the manufacturer is aware of that practice, the company may still be required to address known risks.

Even when patients are undergoing palliative care or high-risk treatment, they are entitled to medical devices that perform as intended.

Potential Injuries Associated With Axios Stent Failures

Patients harmed during stent deployment may experience:

• Internal bleeding
• Gastrointestinal perforation
• Sepsis
• Infection
• Prolonged anesthesia complications
• Emergency surgery
• Organ damage
• Death

Some patients may require extended hospitalization, additional procedures, or intensive care treatment.

Because these stents are often used in already vulnerable patients—such as those with pancreatic disease or severe infection—complications can escalate quickly. A failed deployment can create a chain reaction of medical crises.

Legal Rights of Injured Patients and Families

Medical device manufacturers must design and test products to ensure they function safely during foreseeable use. If a stent fails to deploy or expand as designed, and that failure leads to injury, a claim may involve allegations of:

• Defective design
• Manufacturing defect
• Failure to warn
• Negligent marketing
• Breach of warranty

Patients who suffered serious complications, or families who lost a loved one following a failed procedure involving an Axios stent, may have grounds for legal action.

Compensation in these cases may include:

• Medical expenses
• Future care costs
• Lost income
• Pain and suffering
• Wrongful death damages

An investigation typically involves reviewing surgical records, operative reports, device lot numbers, recall notices, and expert medical analysis.

Axios Stent Injury Lawsuit FAQs

Can I file a lawsuit if the stent was used off-label?
Yes. Off-label use does not automatically bar a claim. If the manufacturer could reasonably foresee that physicians would use the device in certain procedures, and if the device malfunctioned, a lawsuit may still be viable.

What if the surgeon replaced the stent during the procedure?
Even if the device was exchanged, complications caused by prolonged procedure time or trauma from failed deployment may support a claim.

How do I know if an Axios stent was used in my procedure?
Your operative report and hospital billing records typically list the device name and product information. An attorney can assist in obtaining these records.

What must be proven in a defective stent case?
A plaintiff generally must show that the device was defective, that the defect existed when it left the manufacturer’s control, and that it directly caused injury.

Are wrongful death claims possible?
Yes. If a stent malfunction contributed to a patient’s death, the surviving family may pursue compensation under applicable wrongful death laws.

How long do I have to file a claim?
Deadlines vary by state. Because statutes of limitation differ nationwide, timely legal review is important to preserve rights.

Contact Parker Waichman LLP For a Free Case Review

If you or a loved one suffered serious complications during a procedure involving an Axios stent, you may have legal options. Parker Waichman LLP represents individuals nationwide in medical device injury cases. The firm offers a free consultation to review your situation and explain your rights.

Call 1-800-YOUR-LAWYER (1-800-968-7529) today. There is no fee unless compensation is recovered. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.