Neurovascular Stents (stent assisted coiling procedures)
In the 1990s, the use of a neurovascular stent for a procedure call “stent-assisted coiling” was considered a breakthrough treatment for treating brain aneurysms. The medical device offered a non-surgical method to address weak spots in blood vessels in the brain. An aneurysm occurs when a weak point in a vessel allows blood to bulge out the vessel wall. If the aneurysm bursts, it can cause traumatic consequences, particularly when the aneurysm is located in the brain.
A non-stent assisted coiling treatment for an aneurysm involved running a stint from a patient’s leg up into the location of the aneurysm in the brain. The catheter would then inject a string of soft platinum into the aneurysm, which coils upon itself within the “bubble” of the aneurysm. After the platinum was fully deployed, the blood in the aneurysm clots along the coil and eventually fills the either aneurysm, such that is no longer poses the threat of rupture.
The procedure described above worked well, unless the aneurism had a “wide neck.” Where a normal aneurysm looks like a bubble stuck on the side of the vessel, a wide neck aneurysm looks more like a semi-circle. Instead of having a small weak spot in the vessel bulge out into a bubble, the wide neck variety involves a larger weak spot that expands the vessel in a distorted manner. Introducing the platinum coil into the aneurysm is not feasible, as the coil is too exposed to the blood flow and will not remain in place.
Stent-assisted coiling involves an additional step, whereby a wire mesh tube is placed into the artery prior to the coiling. The tube supports the interior of the artery and prevents the platinum coils, which are injected into the aneurysm outside of the mesh tube, from leaving the aneurysm. The mesh remains in the artery permanently after the procedure.
Unfortunately, a number of studies, beginning in 2010, have discovered that outcomes from stent assisted coiling (SAC) are not as effective as first thought. An examination of 1,000 patients revealed that less than half were successful. Permanent neurological problems occurred in 7.4% of the patients. An additional 4.6% of patients died as a result of the procedure. A 2011 study reported 19% of patents having a SAC procedure had a poor clinical outcome, including thrombosis and death. In 2012, a study of 1,500 patients revealed that nearly 19% of all SAC procedures resulted in a thromboembolic event.
There are cases presently pending against stent manufacturers, surgeons, hospitals and other medical providers, for a range of issues, from poor selection of SAC procedure candidates by physicians, improper insertion, and failures by the manufacturer in designing the device, as well as failures in disclosing the dangers of its use.
If you or a loved one has suffered complications, injury or death following a SAC procedure, contact the experienced attorneys at Neumann Law Group for a free consultation.