An aortic stent-graft is placed to reinforce a weakened section of the aorta and redirect blood flow away from an aneurysm.
Endovascular aneurysm repair, or EVAR, is less invasive than open surgery, but the device itself can develop problems months or years after implantation, turning a treated aneurysm into an aortic aneurysm stent failure.
The Law Offices of Sean M. Cleary investigates aortic aneurysm stent complications to determine whether the failure resulted from a device defect and who should be held accountable.
Known Medical Risk or Defective Aneurysm Graft?
A complication after EVAR doesn't always point to a defective aneurysm graft. Since aortic surgery carries inherent risks, some rate of endoleaks, migration, and fracture is expected even when the device is both correctly manufactured and implanted.
When a complication comes from something beyond the expected risk, it can become a potential defective aortic stent claim. This includes a graft that fails in a way or at a rate inconsistent with its design, a component that fractures or separates sooner than the specs suggest, or a manufacturer that failed to warn about a known defect. Reviewing the device, its recall history, and the failure itself is how that distinction gets made.
What Can Go Wrong with an Aortic Stent
Endoleaks, migration, and structural failure are among the most documented endovascular aneurysm repair complications. National cardiology guidelines report that stent-graft fracture and migration occur in roughly 3 to 4 percent of patients within four years of the procedure.
- Endoleak - blood continues flowing into the aneurysm sac after the graft is placed
- Migration - the graft shifts from its intended position, breaking the seal
- Fracture - the metal framework supporting the graft breaks down
- Fabric tear or component separation - a hole or gap allows blood into the sac
- Kinking or occlusion - the graft or a limb becomes bent or blocked
A Type III endoleak is particularly relevant to device claims because it stems from a structural problem with the graft itself, such as a fabric tear or a separation between components.
Recalls Involving Aortic Stent-Grafts
Several aortic stent-graft systems have been the subject of FDA recall actions. A recall or adverse event report does not automatically mean a specific patient's device was defective, but it can support an investigation into whether a known problem contributed to a particular aortic aneurysm stent failure.
- Medtronic Valiant Navion Thoracic Stent Graft System - Class I recall in February 2021 tied to Type IIIb endoleaks, stent fractures, and stent-ring enlargement, affecting more than 33,000 units worldwide
- Endologix AFX Endovascular AAA System - Class I recall tied to Type III endoleak concerns
- Medtronic Endurant, Endurant II, and Endurant IIs - separate recalls involving component detachment during delivery
Symptoms That May Signal a Complication
Some stent-graft complications are only found on routine imaging, while others produce symptoms that call for immediate evaluation. Because these symptoms can appear years after the original procedure, patients and their families are often unaware that a past aneurysm repair could be the cause.
- Sudden or severe abdominal or back pain
- Chest pain or shortness of breath
- Leg pain, weakness, or numbness
- A cold limb or reduced circulation
- Dizziness or fainting
- Signs of infection
Building an EVAR Complications Lawsuit
A claim built around a defective aneurysm graft depends on identifying the exact device involved and matching it against imaging, operative reports, and manufacturer records. Vascular surgeons, interventional radiologists, and biomedical engineers are often needed to determine whether a complication resulted from the device itself rather than the patient's anatomy or the surgical procedure.
- Product name, model and serial number, and implant date
- Operative reports and follow-up CT scans
- Documented endoleak findings or aneurysm measurements
- Recall notices and manufacturer communications
- Records of additional procedures or revision surgery
This distinction affects whether the claim is filed against the manufacturer, the treating physician, or both.
How Can The Law Offices of Sean M. Cleary Help You in an Aortic Stent-Graft Case
Reviewing whether an aortic stent complication stems from a device defect requires close review of imaging records, the device's regulatory and recall history, and input from qualified medical experts. The Law Offices of Sean M. Cleary handles aneurysm graft failure investigations to identify every party that may be responsible for your injury.
If you or a family member experienced an endoleak, migration, fracture, or another complication following aortic aneurysm repair, contact our Miami office for a free consultation to discuss your case.