| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00139-1 |
| Product Name/Description |
MitraClip System (Product Number # MSK02ST) containing the Clip Delivery System (Part number # CDS02ST) and the Steerable Guide Catheter (Part number # SGC01ST)
(Used for reconstruction of the insufficient mitral valve through tissue approximation)
Lot numbers: 50714U1 and higher
ARTG numbers:177709 and 189720 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
16/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Vascular 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 comorbidities.
The mandrel is an internal component of the Clip Delivery System that is integral to Clip function and deployment. Abbott Vascular’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. 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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
While the current Instructions for Use (IFU) require the Arm Positioner to be in a Neutral position prior to turning the Actuator Knob to deploy the Clip, Abbott Vascular is revising the MitraClip IFU Clip deployment sequence to provide additional assurance that tension is completely eliminated prior to deploying the Clip. Abbott Vascular will train all MitraClip implanters on the revised instructions. The customer letter identifies what is changing in the IFU and explains the importance in eliminating tension during the delivery of the clip. Abbott Vascular is continuing to investigate the issue and working with the TGA to ascertain if any further actions need to be undertaken. This action has been closed-out on 17/05/2017. |
| Contact Information |
02 8879 2800 - Abbott Vascular |