Global Recall for Certain Lotus Valve Systems Following Reports of Death, Catastrophic Vessel Trauma
Boston Scientific has issued a voluntary recall for several lots of the Lotus Valve System due to breaks in the release mechanism of the delivery system. These breaks have resulted in three deaths from catastrophic vessel trauma, the company has confirmed to TCTMD.
“This action is related to potential breakage of the release mandrel on Lotus Valve Systems which were manufactured prior to March of 2016,” a Boston Scientific spokesperson said in an email. “The release mandrel is a component of the delivery system that is connected to the release pin which facilitates the release of the valve.
In total, 250 units are being recalled including investigational devices being used in the US-based REPRISE III clinical trial. The malfunction in the device’s delivery system has also led to the need for resheathing and removal of the device, resulting in longer procedure times. The problem is specific to device delivery so there are no safety concerns for patients who already have an implanted Lotus Valve.
The dysfunctional release component was removed and replaced in manufacturing starting in March 2016, and there have been no further reported breaks in the device. For the affected units made before that time, the company is requesting that they be discontinued and returned immediately.
The Lotus Valve System was approved in Europe in October 2013. Boston Scientific then began enrolling US patients in its REPRISE III clinical trial in September 2014, reaching full enrollment December 2015.
Boston Scientific previously recalled 278 units of the device in November 2014, according to the FDA.
Michael H. Wilson is the 2016 recipient of the Jason Kahn Fellowship in Medical Journalism.
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