FDA issues warning on stenting system
NIR ON Ranger with Sox system recalled
In October, the Food and Drug Administration warned hospitals to immediately stop using a new system that implants heart stents after reports that 22 patients were injured and one died. The "NIR ON Ranger with Sox" coronary stent delivery system manufactured by Boston Scientific of Natick, MA, was voluntarily recalled after about 36,000 of the devices were shipped.
The 22 reports included four cases requiring surgical intervention and three incomplete stent deployments or stent migrations. The remainder constituted events that were resolved within the cardiac cath lab.
The device had been popular because the Sox feature — little wings covering the stent’s edges — made it easy to position properly. Boston Scientific reported more than 100 cases of balloon leakage during surgery. Balloon leakage causes the stent to float through the bloodstream, clogging narrow arteries or cutting blood vessel walls. If the partially opened stent can’t be quickly removed, patients may need surgery to retrieve it. The company stated that it has received reports of balloon leaks at a rate of about five per 1,000, with a procedural complication rate of about one per 1,000.