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Health Sciences Authority
Dear Healthcare Professional Letters

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

Audiences

Healthcare professional

Product type

Medical devices

28 November 2017

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

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.


Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in 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://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 ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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