SMART Vascular Stent System 에 대한 현장 안전성 서한

Field Safety Notice

2017-02-16

2017-10-03

Serbia

ALIMSA

https://www.alims.gov.rs/latin/2017/03/10/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-smart-vascular-stent-system/

Following recent complaints and a follow-up investigation, cordis found that the s.M.A.R.T. 5x200mm and 6x200mm was linked to a higher incidence of incidents resulting from difficulty in placing these stents compared to other sizes. the most commonly reported difficulty with the placement of a stent is the inability to place the stent, which led to delays during the procedure due to the preparation of a replacement medical device. however, partial stent placement may cause ischemia or internal bleeding which would require additional intervention. since launching these products in 2013, a total of 3 injuries have been reported worldwide for complaints of stent placement issues (bleeding at the stent insertion site in one case, and causing a thrombus twice) and neither is believed to be in connection with this medical device. however, the causal connection cannot be completely disconnected at this time.