Anaconda™ Longer Leg Iliac Stent Graft System: Complaints of detachment of delivery system sheath from the collar during stent deployment

Terumo Singapore Pte Ltd would like to inform healthcare professionals regarding important information on the Anaconda™ Longer Leg Iliac Stent Graft System, including straight, flared and tapered configurations. The product owner, Vascutek Ltd. has received two complaints, in which the delivery system sheath became detached from the collar during the deployment of the Anaconda™Longer Leg Iliac Leg Stent device from the Delivery System. Deployment of the stent graft was not affected. Vascutek Ltd. will not be taking any action with respect to current products in the field as the severity of this risk is assessed to be negligible and poses no physical risk to the patient. Healthcare professionals are advised to take note of this potential issue and to refer to the IFU for steps to take should this issue occur. Please refer to the letter for details.

 
 
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under 'For Healthcare Professionals’.

Step 2: Click on 'Restricted Content' and log in via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’.

Step 4: Click on the Drug Alert tab to view the DHCPLs.