Advisory Field Safety Notice | TMCI
We are writing to you because our records show that you may have received product from certain lot(s) of AZUR Endovascular Embolization products where a small number of the devices may be missing the implant coil. The products that may be affected by this issue are certain lots of:
- AZUR Peripheral Coil system Detachable 18
- AZUR Peripheral Coil system Detachable 35
A list of lots that may be affected by this issue is provided in Attachment 1.
The AZUR system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
MicroVention has received fifteen (15) complaints related to devices missing the implant coil. There has been no adverse events related to missing coils reported to the manufacturer. MicroVention will continue to monitor any adverse events related to the issue.
Product IFU (Instructions for Use) identifies a series of verification steps that must be performed prior to implant coil deployment including checking the product for irregularities or damage and monitoring for radiopaque marker location and implant presence. See Figure 1 below for the Preparation instructions of the AZUR Detachable System provided in the IFU.
Figure 1 - Preparation instructions of the AZUR Detachable System provided in the IFU
If you follow the pre-deployment instructions during the preparation of the product, you will see whether there is an implant coil present at the end of the delivery pusher. A delivery pusher with an implant coil should look like figure 2 (below) and a delivery pusher that is missing the implant coil will look like figure 3 (below).
Figure 2 – Coil Present
Figure 3 – Coil Missing
A device that has a coil on to the delivery pusher may be used. A device that is missing its implant coil should not be used. A replacement device should be obtained and presence of the coil confirmed per IFU. If the verification steps are not performed per IFU, the user may potentially advance the delivery system without an implant into the peripheral vasculature. Testing shows that the stiffness of the delivery pusher is not higher than that of regular intravascular guidewire. As a result, the company has concluded that the likelihood of patient harm is improbable.
In the event that you encounter a device without a coil, please contact Customer Service to arrange for product return. If you have questions or need assistance, please reach out to the customer service of your local Terumo affiliate, which can be found on the attached MEDICAL FACILITY ACKNOWLEDGMENT FORM.
We ask that you take the following steps immediately:
1. Disseminate the advisory notice to the appropriate personnel.
2. Immediately complete and return the “MEDICAL FACILITY ACKNOWLEDGMENT FORM” form provided.
We regret any inconvenience that this action may cause, but we appreciate your understanding
as we take action to ensure patient safety and customer satisfaction.
Irina Kulinets, PhD, RAC
Sr. Vice President of Regulatory Affairs, Clinical Research and Quality
MicroVention Inc., A TERUMO Group Company