Full article reprinted from "The Gray Sheet" - August 18, 2008
Just as Boston Scientific is beginning to emerge from the quality control cloud it has been living under for the past couple years, FDA revealed Aug. 14 that the firm has recalled its NexStent carotid artery stenting system. Find out more...
Full article reprinted from "The Gray Sheet" - August 18, 2008
More Bad News At Boston Scientific: NexStent Recalled Due To Delivery Flaw
Just as Boston Scientific is beginning to emerge from the quality control cloud it has been living under for the past couple years, FDA revealed Aug. 14 that the firm has recalled its NexStent carotid artery stenting system.
The worldwide recall, initiated by the company June 6, relates to an issue with the NexStent Monorail delivery system and does not apply to already implanted stents. FDA designated it a Class I recall, indicating that use of the device could cause serious injury or death.
Boston Scientific says it received complaints regarding detachment of the tip of the delivery system during the stenting procedure.
According to the firm and FDA, this type of device failure could potentially lead to increased procedure time, vessel wall injury, stroke and/or emergency surgery to remove the detached tip.
The affected NexStent products were manufactured from June 12, 2007, through May 2, 2008, and were distributed from June 19, 2007, through May 5, 2008. In all, 2,690 products were recalled. Of those, 2,217 were distributed and 473 remained in control of the company.
Boston Scientific notified the affected hospitals via a recall letter, which includes instructions on how to return the device.
"At this time, all affected U.S. hospitals have responded to Boston Scientific, and a significant number of the distributed devices have been returned to the company," the firm said in a statement.
This is the second recall for the NexStent system since its February 2007 U.S. launch; the firm also initiated a worldwide Class II recall in May 2007 due to a report that the device failed to deploy when the outer catheter did not pull back and expose the self-expanding stent.
NexStent, developed by EndoTex, was approved by FDA in October 2006 for use in patients with carotid artery disease who are at high risk for surgery. Boston Scientific, which has sold the device in Europe since 2005, acquired EndoTex, along with the rights to market NexStent in the U.S., shortly after PMA approval.
The stents are used to hold open the carotid arteries and restore blood flow to the brain in patients at risk of stroke due to blockages caused by plaque formation.
The Class I recall is a blow for Boston Scientific, which has strived to repair its damaged reputation since a previous rash of defibrillator recalls and a corporate-wide FDA warning letter in early 2006.
Among the previous extensively and negatively publicized recalls, the firm in 2006 had to notify physicians about problems with Vitality implantable cardioverter defibrillators and Contak Renewal pacemaker-defibrillators, relating to flawed capacitors that could result in premature battery depletion (1"The Gray Sheet" May 22, 2006, p. 11). The defective products were manufactured by Guidant, which Boston Scientific acquired in April 2006.
The next year, Boston Scientific recalled certain Contak and Vitality defibrillators, also because their batteries were shown to potentially deplete earlier than expected (2"The Gray Sheet" April 16, 2007, p. 7).
Warning Letter Resolution Expected Soon
Boston Scientific has been taking extensive steps to revamp its quality systems in the wake of the January 2006 corporate warning letter, which has prevented the firm from bringing new products to market (3"The Gray Sheet" Jan. 30, 2006, p. 7).
During Boston Scientific's second quarter earnings call July 22, CEO Jim Tobin said the firm expected to finally resolve the warning letter by the end of this month (4"The Gray Sheet" July 28, 2008, p. 10).
That will pave the way for FDA approval of Boston Scientific's Taxus Liberté second-generation paclitaxel-eluting coronary stent system, among other products. The firm received an "approvable" letter for the device in March, but FDA refused to grant final approval until the agency is satisfied that the quality systems issues that prompted the letter are resolved.
- Brooke McManus
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