Recommendations for Clinical Use OPTEASE® Retrievable Vena Cava Filter

Johnson & Johnson Medical Singapore would like to inform healthcare professionals that Cordis Corporation (“Cordis”) has received a total of 16 reports overseas relating to an incorrect implantation of Cordis OPTEASE® Retrievable Vena Cava Filter, through post-market surveillance. Cordis OPTEASE® Retrievable Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism via percutaneous placement in the vena cava. Five of these reports were received in the last 6 months. Although no deaths had resulted from this issue, open heart surgeries were required for 2 cases due to the migration of the filters to the right heart. Investigation of the 16 cases revealed that the filter was implanted with the retrieval hook incorrectly oriented towards the superior vena cava. As a precautionary measure, Cordis has initiated a preventive action to highlight to local users the proper device implantation procedure. There is no product defect related to this issue. Healthcare professionals are advised to refer to the letter for the 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.