The FDA recently announced that Endologix is recalling the Ovation iX Abdominal Stent Graft Systems used in surgeries to repair abdominal aortic aneurysms. The particular abdominal stent recall is due to a material weakness, which according to the FDA, occurred during the manufacturing process of the stent and can lead to serious health complications.
Have your or a loved one recently had surgery to repair an abdominal aneurysm? Are you experiencing complications or did you experience problems after the abdominal aneurysm repair? The side effects you’re experiencing may be due to a recently recalled stent system used in your surgery.
According to the FDA recall alert notice, the device uses a type of polymer technique to prevent blood from flowing into the aneurysm and to secure the Ovation device. Unfortunately, this polymer can leak during implantation due to a material weakness caused in manufacturing. The weakness in the material can lead to blood continuing to flow into the aneurysm or even the liquid polymer leaking into the body.
According to the FDA, here are some of the potential consequences as a result of the Ovation iX Abdominal Stent Graft System manufacturing failure:
- Severe allergic reactions
- Unstable blood pressure
- Tissue damage
- Oran failure
- Cardiac arrest
- Central nervous systems problem
- Death
Suppose you recently had surgery to treat abdominal aortic aneurysms or had a procedure to replace the Ovation iX Stent Graft Systems and are in pain due to the stent. In that case, you may be eligible for compensation due to the physical, financial and emotional hardship you’ve endured.
An experienced attorney can help you navigate the complexities your case may involve. For almost 20 years, Thomas Creech has represented clients in various personal injury cases, including Medical Malpractice and Product Liability.
To find out if you have a case, please don’t hesitate to contact us by phone at 864-235-4999 or through our contact form below.
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