Medical device manufacturer, Abbott Vascular, has issued a medical device safety alert concerning its MitraClip XTR Clip Delivery System [Product Number: CDS0602-XTR; UDI: 08717648226366]. The MitraClip System is intended for reconstruction of the insufficient mitral valve through tissue approximation.
The manufacturer has confirmed reports of XTR Clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied to the Clip during implantation. Once the Clip becomes nonfunctional, the inability to close and remove the device has led to surgery or additional intervention. The manufacturer calculates these events to be occurring at a rate of less than 0.16%. There have been incidents (0.02%) where post-procedure patient death was reported following complications associated with surgery and/or patient comorbidities.
According to the manufacturer, investigation of the events determined that under normal use conditions, the failure mode will not occur. To prevent unintended excessive force from being applied to the Clip, revised instructions for performing the steps "Establish Final Arm Angle" and "Invert the Clip Arms" were developed. The revised instructions will be applied to the shared MitraClip XTR and NTR Clip Delivery System Instructions for Use (IFU). Unintentional excessive force applied to the MitraClip NTR Clip Delivery System during "Establish Final Arm Angle" can result in unexpected movement of Clip arms; however, unlike XTR, the NTR Clip does not become damaged and remains functional. Adhering to the revised IFU sections for both product platforms will ensure consistency of use. Patients who have previously had Clips implanted are not affected by this action.
Affected users are instructed to take the following actions: -
The communication provides revised IFU steps for use with current inventory of MitraClip XTR/NTR Clip Delivery Systems. The instructions explain the changes to the steps for use and emphasizes the importance of preventing unintended excessive force to the Clip. The revised instruction steps provided in the communication will be updated in MitraClip XTR/NTR Clip Delivery System IFU and included in associated training.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 3 May 2019