Update to the restenosis rate of BARD® LIFESTREAM™ Balloon Expandable Vascular Covered Stent

Bard Singapore Pte Ltd would like to update healthcare professionals on the restenosis rate of BARD®LIFESTREAM™ Balloon Expandable Vascular Covered Stent. A number of complaints were reported for restenosis following normal clinical use and also from follow up to the BOLSTER Clinical Trial. No patient injuries were reported. The complaint rate for restenosis (0.04%) exceeds the rate listed in the Failure Modes Effects Analysis (0.01%). The clinical study results will be included in the Instructions For Use of all future units distributed by ClearStream (BD). No unit needs to be returned. Healthcare professionals are advised to follow up on patients implanted with the device as per standard procedures. 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.