Medical device manufacturer, Abbott Vascular, has issued a medical device safety alert concerning its MitraClip Clip Delivery System [Product number: MSK02ST]. The System contains the Clip Delivery System [Product number: CDS02ST] and the Steerable Guide Catheter [Product number: SGC01ST].
The manufacturer has recently received nine reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob [Lot number 50714U1 and greater] where a user attempted implanting a MitraClip, but the Clip could not be detached from the delivery system due to a mandrel fracture. These cases resulted in surgical interventions and, in one case; the patient expired post-operatively due to severe co-morbidities.
The manufacturer's investigation determined that a mandrel fracture may occur if tension is present on the mandrel when turning the Actuator Knob to deploy the Clip. The tension is present if the Arm Positioner is on the "Closed" side of Neutral, as opposed to being in the Neutral position during Clip deployment.
The manufacturer is revising the MitraClip IFU Clip deployment sequence to provide additional assurance that tension is completely eliminated prior to deploying the Clip. The manufacturer will train all MitraClip implanters on the revised instructions. There is no need to return any product to the manufacturer.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 February 2016