The Law Firm of Hanson Fuller Lina is representing two orphaned children of a 49-year-old man who recently died after a Medtronic Euphora noncompliant balloon failed to deflate within one of his main arteries. Despite the surgeon’s multiple efforts to deflate the balloon, the product failed repeatedly until it was too late.
When a physician expands a stent in your heart to improve your blood flow, both you and your physician expect the medical devices to function safely. After all, they supposedly are designed, manufactured and marketed to perform this exact function. If a balloon is inflated within a stent, but the balloon unexpectedly fails to deflate, blood flow to the heart is completely obstructed. The outcomes from this type of product failure are often catastrophic.
Sadly, for some patients and doctors, this nightmare scenario has occurred with alarming regularity, as documented in the FDA’s MAUDE database. In recent years, there have been numerous reports of deflation failures involving Medtronic’s noncompliant balloons during stent expansion procedures. In most of those cases, the balloon is inflated to expand the stent, but the balloon then fails to deflate, completely occluding the flow of blood to the heart. In some of these cases, the results have been fatal.
If you or a family member suffered injuries from a Medtronic balloon catheter, the Law Firm of Hanson Fuller Lina wants to hear from you.
A Documented Pattern of Failure
According to the FDA’s Manufacturer and User Facility Device Experience (“MAUDE”) Database, more than 100 independent “adverse event reports” of deflation failures and defects have been filed involving Medtronic’s noncompliant balloon devices, including at least 5 reported deaths in recent years (as of the date of this posting). Tellingly, the number of adverse reports continues to increase on an annual basis.
According to Medtronic’s marketing materials, the NC Euphora balloon is designed for “controlled, high-pressure” dilation in coronary angioplasty procedures, specifically to expand coronary stents to improve blood flow. The Medtronic NC Euphora balloon dilation catheter is supposed to fully deflate promptly and collapse to a low profile for removal after the balloon performs its intended dilation function. Deflation of the device is not optional. Deflation errors simply cannot occur.
Serious Injuries Linked to Medtronic Balloon Catheters
If a balloon catheter device fails to deflate, blood flow cannot be restored, and life-threatening vessel occlusion inevitably will occur. The failure of a Medtronic balloon to deflate during a coronary angioplasty procedure is a life-threatening event and consistent with a defective product.
What You Should Do Right Now
If you or a loved one was the victim of a failed balloon during a stenting procedure, or if you believe something went wrong during the placement of a stent, you should act quickly to protect your legal rights. These cases are time-sensitive — statutes of limitations apply and evidence must be preserved quickly. Do not wait. Victims and their families may be entitled to compensation for medical expenses, pain and suffering, lost income, and wrongful death damages.
Contact Hanson Fuller Lina for a free, confidential case evaluation.