Rare Risk of Damage to Heart Valve if the Device is Not Applied Correctly

Published date : 26 March 2013
Article date : 26 March 2013

 

Mass Device reports that Abbott Vascular has alerted clinicians on a slight risk that its MitraClip heart valve implant could be damaged if it is not applied correctly.
 
The manufacturer said in a field safety notice that it has received 4 reports since 2008 in which the device system's 'actuator knob' was turned in the wrong direction thus damaging the clip and preventing deployment. 
 
Abbott's spokesman Jonathon Hamilton told MassDevice.com that these 4 cases represent only 0.05% of implantations and that the company has added a directional arrow on the actuator knob of newly manufactured devices to assist proper clip deployment.
 
Source: MassDevice.com, 25 March 2013 
 
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